
Search Results
Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF (STRONG-CF)
There are currently two main ways of measuring nutrition in the Cystic Fibrosis (CF) population: body mass index (BMI) and laboratory values. This study plans to look at more ways to measure nutrition, and body composition, like the percentages of fat, bone and muscle in your body. One of the ways we will measure these items is by using dual energy X-ray absorptiometry (DXA) scan, which is a type of x-ray. This study hopes to provide researchers with more detailed information about nutrition and body composition in adults with CF.
• diagnosed with Cystic Fibrosis
• clinically stable with no significant changes in health status within the 14 days prior to the first study visit
• no prior solid organ transplantation
• no initiation of an investigation drug within 28 days before
• no initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator) within 28 days
• no acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 14 days
Non-Invasive Sleep and Circadian Rhythm Assessment Pre- and Post-surgery in Cushing Disease
The goal of this study is to see if using in-home sleep activity monitoring may help understand sleep problems that occur before and after surgical treatment for Cushing Disease.
• Aged 18 years or older
• Their own legal guardian
• Confirmed Cushing's Disease (CD) by biochemical test and brain MRI imaging
• Scheduled for surgery to treat CD
• Receiving care through an Endocrinology or Neurosurgery clinic
• Able to complete the self-report their health/wellbeing and sleep diary information
• Biochemical and/or brain MRI imaging test with inconclusive results
• Patients not electing for surgical intervention for CD
Bladder Management Patient Reported Outcomes for Young Adults with Spina Bifida
The purpose of this study is to determine how different bladder management methods affect the quality of life for young people with spina bifida. We hope to find out if certain bladder management methods are associated with a better quality of life. This information could help doctors make better treatment decisions and counsel young people living with spina bifida.
• at least 14 years old
• diagnosis of spina bifida
• able to effectively communicate in English
• reconstructive surgery or urinary diversion in the last 3 months
• admitted to the hospital admission in the last month
Measurement of Upper Aerodigestive Tract Pressures During Phonation
The purpose of this pilot research study is to test whether a tool called “High-Resolution Manometry” can diagnose laryngeal dystonia (also known as spasmodic dysphonia) and measure how well treatment works. High-Resolution Manometry measures pressures from a small catheter that is passed from your nose into your throat. We believe that pressures in the throat might be different for people with laryngeal dystonia than for people without laryngeal dystonia, or with other types of voice disorders. If we can diagnose laryngeal dystonia shortly after symptoms start, we can get patients the treatment they need sooner.
• experienced improvement in voice quality following injection of botulinum toxin into the thyroarytenoid complex
• received their most-recent injection within 6 months
• age 18-80 years old
• able to read and write in English
• For Healthy Controls:
• age 18-80
• have no known voice problem
• able to read and write in English Patients with Muscle Tension Dysphonia:
• Age 18-80 (age-and sex matched to adductor laryngeal dystonia)
• Diagnosis of primary muscle tension dysphonia by a laryngologist and speech pathologist in the “...absence of current organic vocal fold pathology, [and] without obvious…neurologic etiology.”18
• Able to read and write in English
• Muscle tension dysphonia patients who either haven’t started voice therapy, or for whom symptoms persisted despite voice therapy
• diagnosis of vocal tremor, abductor laryngeal dystonia, any type of vocal fold lesion, or vocal fold paralysis
• known swallowing disorder (oropharyngeal or esophageal), with the exception of transient post-botulinum toxin injection-induced dysphagia
• pregnant
• prisoners
• allergy to topical anesthetic
• cannot fast for 6 hours (4 hour fast prior to study, up to 2 hours to complete the study)
• recent facial trauma
• recent nasal, pharyngeal, laryngeal, or esophageal surgery or obstruction
MT2022-45 Primary Immune Regulatory Disorders (PIRD): Longitudinal Study of Clinical Presentation, Treatment and Outcomes
Primary Immune Regulatory Disorders (PIRD disorders) are a group of diseases that cause the immune system to function abnormally and cause infections, autoimmunity or inflammation that can begin early in life. PIRD is usually caused by changes in genes in DNA. Researchers are trying to learn what types of medical problems patients with PIRD have and how these respond to treatment. Researchers also want to learn which genes cause PIRD and how it can cause the medical problems of PIRD.
• age 0 to 99 years
• diagnosis of immune-mediated bowel disease affecting at least one segment of the bowel
• evidence of interstitial lung disease (ground-glass opacities) or pulmonary nodules/cysts
• decreased lung function
• additional inclusion and exclusion criteria apply (study staff will review)
• also enrolling parent, sibling, or child of eligible participants
• documented HIV infection
A multicenter, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult atypical hemolytic uremic syndrome (aHUS) patients who are naive to complement inhibitor therapy (APPELHUS)
To evaluate the efficacy and safety of iptacopan at a dose of 200 mg twice a day for 52 weeks in patients with atypical hemolytic uremic syndrome (aHUS).
• at least 18 years old
• evidence of active Thrombotic Microangiopathy (TMA)
• previous or ongoing treatment with complement inhibitors, including anti-C5 antibody
• ADAMTS13 deficiency
• positive test for Shiga toxin * direct Coombs test
• had a bone marrow transplant or hematopoietic stem cell transplant, or a heart, lung, small bowel, pancreas or live transplant
ELEVATE, a global observational longitudinal prospective registry of patients with acute hepatic porphyria (AHP) (ELEVATE)
This is a global, multicenter, prospective, observational, longitudinal registry conducted to characterize the natural history and real-world clinical management of patients diagnosed with AHP. This protocol will not recommend the use of any specific treatments, visits, or procedures. No medication is provided as part of registry participation.
Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents
The purpose of this study is to examine a new, experimental treatment for adolescents at risk for suicide attempts called neurofeedback training. In neurofeedback training, you are trying to control your brain function on purpose. In this study, your child will see their brain activity (displayed like a thermometer). He/she will recall positive memories to try to change the levels of their brain activity shown on the visual thermometer inside a scanner.
• any gender identity
• 11-17 years old
• past suicide attempt and/or current suicide ideation
• Autism Spectrum Disorder
• Cognitive Developmental Delay (IQ < 75 i.e.intellectual disability)
• diagnosis of Schizophrenia
Effectiveness of Screening and Decolonization of S. aureus to Prevent S. aureus Surgical Site Infections in Surgery Outpatients
The purpose of this study is to determine the most effective ways to get rid of Staph aureus on body surfaces before surgery. We will determine if the participants can effectively get rid of the bacteria with the simple application of various treatment methods assigned to them. We will study if these methods are useful and cost effective in preventing the infections after surgery.
• at least 18 years old
• people who are scheduled for orthopedic, urology, neuro, otolaryngology, plastic and general surgery or OB/GYN surgery
• surgery is scheduled for at least 10 days following entry into the study
• have not taken antibiotics in the week before surgery
• will have a skin incision
• surgery scheduled less than 10 days after the baseline cultures
HM2024-18 A Phase 1/2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis
This study is testing an compound called TP-3654, which is an investigational product being developed for Myelofibrosis.
• diagnosis of primary or secondary myelofibrosis
• may be restricted from strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria which are specified by diagnosis
• eligible for allogeneic bone marrow or stem cell transplantation
• history of symptomatic congestive heart failure, or myocardial infarction, or uncontrolled arrhythmia within the past 6 months
• history of chronic liver disease
• women who are pregnant or breastfeeding -see link to clinicaltrials.gov for complete exclusion criteria which are specified by diagnosis
A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors
This study aims to evaluate the safety and tolerability of ADRX-0405 in people with advanced cancer and determine the optimal dose for treatment.
• age 18 or older
• Phase 1a: confirmed advanced solid tumors (metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC))
• Phase 1b: confirmed prostate adenocarcinoma that is confirmed to be castration resistant and that is intolerant/resistant to standard of care (SOC) therapies
• see link to clinicaltrials.gov for complete inclusion criteria
• active and uncontrolled central nervous system metastases
• have received an anticancer or investigational therapy prior to the first dose of study drug
• history of ILD/pneumonitis requiring steroid treatment within the past 2 years, current ILD/pneumonitis, or an active infection requiring systemic antibiotics (prophylactic antibiotics permitted)
• see link to clinicaltrials.gov for complete exclusion criteria
Geniculate Artery Embolization
Osteoarthritis (OA) is a leading cause of disability and chronic pain that reduces physical activity and daily activities. In this clinical research study, the goal is to learn more about geniculate artery (located in the knee) embolization (GAE) treatment to see if it will reduce pain as well as stiffness and difficulty performing daily activities caused by knee OA and if it can be performed safely.
• osteoarthritis of the one knee with symptoms that have not improved after at least 3 months of treatment such as PT, injection, medications,
• partial knee replacement and total knee arthroplasty are not currently options (may be in the future)
• 40-70 years of age
• weight greater than 250 pounds
• smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
• diabetic with A1C greater than 9%
• advanced peripheral arterial disease
A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician s Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma (FIRST-308) (FIRST-308)
The main purpose of this study is to learn how well tinengotinib works and how safe tinengotinib is compared with the study doctor’s choice of chemotherapy treatment. The purpose of Part A of the study will be to determine the best dose of tinengotinib to use in Part B of the study. The purpose of Part B is to learn more about how well tinengotinib works and how safe it is compared with the study doctor’s choice of treatment.
• adenocarcinoma of biliary origin (bile ducts) that can't be surgically removed or is metastatic (spread to other areas of the body)
• cancer has FGFR2 fusion/rearrangement gene status
• received at least one line of prior chemotherapy and one FDA approved FGFR inhibitor
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• received two or more FGFR inhibitors, either approved or investigational drugs
• brain or central nervous system (CNS) metastases
• presence of another cancer that requires treatment
• uncontrolled hypertension (blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite treatment with antihypertensive medications)
CONQUER Protocol Number 001: COllaborative, National QUality and Efficacy Registry for Tracking Disease Progression in Systemic Sclerosis (Scleroderma) Patients (CONQUER)
The purpose of this study is to develop a cohort of patients with early scleroderma, and to collect data on clinical outcomes, radiological tests, laboratory tests and to obtain biological specimens for testing.We hope to explore medical care and the impact of SSc on patients' daily lives through various questionnaires that will be collected during study participation. By looking at all of the areas mentioned, we hope to find out information about SSc that will help treat future patients, develop new treatments, and work towards a cure.
• at least 18 years old
• have a diagnosis of systemic sclerosis
• less than 5 years from onset of first symptom attributed to systemic sclerosis
• cognitive impairment that interferes with ability to participate in the study
• unable to speak, read, and write English
A seamless, Phase 1b/2 multiple ascending dose/proof of concept study of XTMAB-16 in patients with pulmonary sarcoidosis with or without extrapulmonary manifestations
XTMAB-16 is a new, experimental drug and is part of a group of drugs known as tumor necrosis factor alpha (TNF α) inhibitors. TNF is a protein in your body that causes inflammation. TNF α inhibitors work by suppressing part of the immune response along with reducing inflammation. We are conducting this research study to see if XTMAB-16 will help in the treatment of pulmonary sarcoidosis.
• Diagnosis of pulmonary sarcoidosis with some respiratory symptoms
• Must be taking 7.5 to 25 mg of prednisone daily and will to taper down dose
• Must be on an additional medication for the treatment of sarcoidosis
• Please contact umnsarc@umn.edu if you have any questions
• Pregnancy or breast-feeding
A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated with Lonapegsomatropin (SkyPASS) (SkyPASS)
The purpose of this study is to evaluate the long-term safety and effectiveness of Skytrofa treatment in children growth hormone deficiency. Patient care will follow the normal treatment practices at the clinic. No additional visits will be performed beyond the usual clinical practice.
• 1 to 18 years old
• on treatment with SKYTROFA (lonapegsomatropin)
• participating in any interventional clinical study for short stature
Biologic Abatement and Capturing Kids Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK OFF JSpA) (BACK-OFF JSpA)
This study is enrolling participants who have been diagnosed with juvenile spondyloarthritis, are taking a tumor necrosis factor inhibitor (TNFi) and have reached a clinically inactive disease state for a minimum of six months. Researchers want to know if children who have maintained inactive disease for at least 6 months can maintain quiet disease without taking their medication as frequently or stop the TNFi therapy. Quiet disease means that disease related symptoms are not active or being experienced in the patient. Researchers also want to know the safest method to bring patients off medication. If a flare does occur during therapy reduction, researchers want to find out whether they can predict when a flare is most likely to happen, and how quickly an inactive disease state can be recaptured.
• age 8 to 21 years
• juvenile SpA diagnosis symptom with symptoms starting before their 16th birthday
• currently taking one of the following therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab) at standard doses
• have reached a clinically inactive state for at least 6 months
• English speaking or Spanish speaking
• willing to taper off medications
• History of inflammatory bowel disease or history of uveitis
• psoriasis that started before TNFi therapy or psoriasis that started after TNFi therapy and has required more than topical therapy for control
Assessment of usability and satisfaction with a take-home device presenting sound and body stimulation for back pain
The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP) compared to a group of participants who are engaging in integrative health practices. The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. Findings from this usability pilot study could help refine the approach and the multi-modal device for a future intervention study in cLBP participants.
• must have chronic lower back pain, defined as back pain lasting 3 or more months,
• willing to travel to the University of Minnesota and commit to the study duration
• cannot have any implanted stimulation devices
Brain Health Registry and Biospecimen Repository
The Brain Health Registry and Biospecimen Repository will create a research framework aiming to help us understand the causes of memory loss in Alzheimer's disease and other neurodegenerative disorders. We would like to recruit research participants 45+ years and up without any memory complaints, participants subjectively reporting memory complaints, and participants suffering from mild cognitive impairment or dementia symptoms due to neurodegenerative diseases. We will ask study participants about their medical history, their demographics, their social determinants of health, do a sleep quality assessment, and do neuropsychometric assessments. We will also create a biospecimen repository of blood, tissue and cerebral spinal fluid samples from the above participants.
HEALthy Brain and Child Development Study
We are doing a study to learn how children develop early in life. There will be about 300 parent-child pairs in this study in Minnesota and about 7,500 pairs total across the country. There will be study visits from pregnancy through the first 10 years of your child’s life.
• at least 18 years old
• currently pregnant
• speak English
Assessments of sound perception and brain activation in response to paired sound and electrical stimulation of surface ear regions
We are investigating how paired non-invasive electrical stimulation of surface body regions and sound changes sound perception and tinnitus. Body stimulation regions include: external ear/behind the ear, shoulder, neck, forearm, hand, and upper arm. We aim to better understand the optimal conditions of this paired stimulation, which opens opportunities for applying this method to improving hearing loss or tinnitus. We are studying three groups of people: those with normal hearing, those with mild to moderate hearing loss, and those with tinnitus.
• normal hearing or hearing loss with or without tinnitus
• not users of Cochlear Implant or hearing aids
Neural and Behavioral Markers of the Temporal Dynamics of Language Planning and Phonological Working Memory Processes in Persons Who Stutter
This is a study of persons who do and do not stutter between ages 7 and 65 years. This study is trying to figure out how attention skills influence memory, language, and speech fluency skills.
• age 7 through 65 years
• remaining eligibility will be determined based on response to an intake survey
Neural Correlates of Goal Prioritization and Conscientiousness
This research will use neuroimaging to study the brain systems involved in prioritizing goals effectively, as well as testing whether variation in those systems is associated with the personality trait conscientiousness, which reflects organization, self-discipline, and industriousness and predicts important health and other life outcomes.
• age 20 - 50
• right handed
• no major psychiatric illness
• claustrophobia
• any metal or devices in the body (e.g., pace makers, aneurysm clips etc.)
A Phase 2 Randomized Trial of Neoadjuvant Enoblituzumab versus Standard of Care in Men with High-Risk Localized Prostate Cancer: The Help Elucidate & Attack Longitudinally (HEAT) Prostate Cancer Randomized Study (HEAT)
This study aims to improve prostate cancer treatment by testing a drug, enoblituzumab, which targets a protein called B7-H3. Previous research suggests it might boost the immune system to fight cancer. The objective is to see if it delays cancer return compared to standard treatment and identify who responds best.
• confirmed adenocarcinoma of the prostate
• an initial prostate biopsy within 3 months of enrollment is available for review, showing at least 3 positive cores, including one with ≥50% involvement and Gleason ≥8
• radical prostatectomy has been scheduled
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• known lymph node involvement on CT or distant metastases on CT or bone scan; non-adenocarcinoma prostate cancers
• previous or concurrent use of radiation, hormonal, biologic, chemotherapy, immunotherapy, experimental agents, 5α-reductase inhibitors, or systemic corticosteroids
• autoimmune diseases requiring systemic immunosuppression; malignancy within the last 3 years; uncontrolled major infections or illnesses
MT2024-16: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Hidradenitis Suppurativa (Regulate-HS)
This research study is for people who have Hidradenitis Suppurativa (HS) and it is moderate or severe in intensity and have been treated with at least one conventional therapy for HS. This study involves the investigational drug SBT777101, which is created by genetically modifying a patient’s own immune cells. The word “investigational” means that this drug has not been approved by the U.S. Food and Drug Administration (FDA) for marketing. SBT777101 is being developed to treat people with hidradenitis suppurativa (HS).
A Randomized Phase II Study of Letrozole Versus Observation in Patients with Newly Diagnosed Uterine Leiomyosarcoma
The purpose of this study is to find out if the drug letrozole is better or worse than not receiving treatment (called observation) following surgery for your type of cancer. Letrozole could prevent your cancer from returning but the cancer could grow while on treatment. There is currently no definitive data to support the use of Letrozole treatment for early stage Leiomyosarcoma. Letrozole has already been FDA-approved to treat other cancers, but it is investigational in this research.
• confirmed newly diagnosed uterine leiomyosarcoma with disease limited to the uterus
• tumor expresses ER positivity by immunohistochemistry
• completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks prior
• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• able to swallow oral medication
• see link to clinicaltrials.gov for complete inclusion criteria
• any other severe disease
• also has another cancer or has been treated for cancer in the past three years
• women who are pregnant or breastfeeding
• currently receiving chemotherapy or radiation therapy
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection (Solar-Stage)
The purpose of this study is to test the safety and effectiveness of Copper Cu 64 PSMA I&T in detecting lesions during a PET scan. This study is open to men with newly diagnosed prostate cancer who plan to have a prostatectomy and lymph node removal. Copper Cu 64 PSMA I&T is an investigational PET imaging agent, given to you via IV injection, similar to the way other imaging agents are used in many other types of scans. Cu 64 specifically targets the prostate specific membrane antigen (PSMA) that is found on the surface of metastatic prostate cancer cells. Increased image contrast may make it easier for the doctor to see smaller lesions compared to other imaging agents.
• newly diagnosed with prostate adenocarcinoma with intermediate / high risk features
• planned prostatectomy with pelvic lymph node dissection
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• received any therapy for prostate cancer before surgery
• not able to have a PET scan
• had a prostate-specific membrane antigen (PSMA) PET scan in the past 90 days
A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy versus Standard of Care in Participants with Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (AZUR-2)
The purpose of the study is to evaluate the safety and effectiveness of dostarlimab as compared with standard treatment with surgery in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer
• has adenocarcinoma of the colon that has not been treated
• plan is to do surgery for the cancer that is T4N0 or Stage III
• tumor shows presence of either dMMR status or MSI-H
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
• history of interstitial lung disease or pneumonitis
• cirrhosis or current unstable liver or biliary disease
• history of allogenic stem cell transplantation or organ transplantation
• women who are pregnant, breastfeeding, or expecting to conceive children during the study
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy (ASCENT-GYN-01)
The purpose of this research study is to learn if sacituzumab govitecan (also called SG or Trodelvy®) can improve lifespan and delay the growth or spread of the disease in participants with endometrial cancer when compared to chemotherapy (doxorubicin or paclitaxel).
• diagnosis of endometrial cancer that has not responded to treatment or has recurred
• up to 3 prior lines of systemic therapy including platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination or separately
• assigned female at birth
• if of child bearing age, must use birth control as specified by the study
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• eligible for rechallenge with platinum-based chemotherapy
• continue to have significant side effects from treatment
• active second cancer or a history of another active cancer in the past 3 years
• a history of significant cardiovascular disease including myocardial infarction, significant arrhythmia, congestive heart failure
• history of HIV-1 or 2
• active hepatitis B virus (HBV) or hepatitis C virus (HCV)
• women who are pregnant or breast feeding
A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) versus Surgically Targeted Radiation Therapy (STaRT) with Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors.
The purpose of this research study is to compare surgical tumor removal followed by stereotactic radiotherapy (SRT) to surgical tumor removal followed by radiation therapy delivered by surgically implanted GammaTilesTM (GT). A GammaTile (GT) is an FDA cleared device used to provide radiation therapy following the removal of a brain tumor. GT are small (2cm x 2cm x 0.4cm) collagen squares/tiles that contain sources of radiation that look like grains of rice. If assigned to the GT study group, the doctor will place tiles containing the radiation sources in the cavity left after surgically removing the brain tumor. They do not need to be removed as the collagen tiles will be absorbed and the radiation sources can be left in place. If assigned to the SRT study group, SRT will take place 3-4 weeks after surgery and uses external beams to deliver radiation to the cavity left after surgically removing the brain tumor.
• one to four newly diagnosed brain metastases, from an extracranial primary tumor (found on MRI)
• planned surgery to remove one lesion is between 2.5 cm and 5.0 cm in size, other lesions must be less than 4.0 cm in size
• able to complete an MRI of the head with contrast
• fluent in English or Spanish language
• additional criteria apply, contact study staff
• past radiation or surgical therapy newly diagnosed lesion(s)
• more than 4 newly diagnosed metastases on MRI
• psychiatric, neurologic disease, injury impacting cognition