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7T MRI Scan for Detecting Melanoma Brain Tumors
N/A
Recruiting
Led By Lindsay Hwang
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status (KPS) >= 70
Melanoma patients with new untreated brain metastases seen on CE 3T MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline
Awards & highlights
Study Summary
This trial uses a 7T MRI machine to see if it can better detect melanoma brain metastases than the standard 3T MRI machine.
Who is the study for?
This trial is for adults with melanoma that may have spread to the brain. Participants must be able to undergo MRI scans without distress, have a performance status indicating they can carry out daily activities, and agree to use contraception. It's not suitable for those with poor kidney function, recent neurosurgery or radiotherapy, uncontrolled illnesses, claustrophobia severe enough to prevent MRI scans, incompatible implants, or allergies to contrast agents used in MRIs.Check my eligibility
What is being tested?
The study is testing whether a high-resolution 7 Tesla (7T) MRI scan can detect brain metastases from melanoma more effectively than the standard 3 Tesla (3T) MRI scan. The goal is early detection of cancer spread which could lead to better treatment outcomes.See study design
What are the potential side effects?
While there are typically no side effects associated with undergoing an MRI scan itself, some individuals might experience discomfort lying still during the procedure or anxiety due to the enclosed space of the scanner. There's also a small risk of allergic reaction to gadolinium-based contrast agents used during imaging.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself but may not be able to do active work.
Select...
I have melanoma with new brain metastases not yet treated.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Presence or absence of brain metastases on 7 tesla (T) magnetic resonance imaging (MRI) as compared to the standard of care 3T MRI
Primary tumor size
Other outcome measures
Incidence of diagnosis of leptomeningeal disease on CE 7T MRI brain
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (7T MRI)Experimental Treatment1 Intervention
Within 2 weeks of initial standard of care 3T MRI, patients undergo 7T MRI scan with and without contrast over 1-2 hours.
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,263 Total Patients Enrolled
16 Trials studying Melanoma
774 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,669 Previous Clinical Trials
40,926,376 Total Patients Enrolled
557 Trials studying Melanoma
193,165 Patients Enrolled for Melanoma
Lindsay HwangPrincipal InvestigatorUniversity of Southern California
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to care for myself but may not be able to do active work.I have melanoma with new brain metastases not yet treated.I had brain radiation for metastases more than 30 days ago.I agree to use birth control during and 90 days after the study, and I am not pregnant.I had brain surgery more than 30 days ago or have recovered from it.You have had allergic reactions to similar substances as the contrast agent used in the study.I cannot undergo MRI scans due to severe claustrophobia or anxiety.I am 18 years old or older.You can stay still and calm during an MRI scan without feeling anxious or uncomfortable.My kidney function is very low or I am on dialysis.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I haven't had brain-directed radiotherapy in the last 30 days or recovered from its side effects.I have had treatments like chemotherapy or immunotherapy before.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (7T MRI)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been accepted into this scientific research project?
"Confirmation can be found on clinicaltrials.gov, indicating that the trial is actively searching for volunteers. This medical research was first announced on June 25th 2021 and has since been updated in mid-November 2022; it aims to recruit a total of 25 participants from one location."
Answered by AI
Is this research actively seeking participants?
"Affirmative, the information located on clinicaltrials.gov points to this study actively seeking participants. First posted in June 2021 and last edited November 2022, 25 individuals are needed at a single site for this trial."
Answered by AI
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