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Diagnostic Imaging
DCE-MRI for Brain Tumor Diagnosis
N/A
Waitlist Available
Led By Krishna Nayak, PhD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is studying how well a special type of MRI works in diagnosing brain cancer and other conditions where the blood-brain barrier is compromised.
Who is the study for?
This trial is for adults with recurrent high-grade glioma or melanoma that has spread to the brain. Participants must have finished previous treatments at least 30 days prior and have good organ function and performance status. Pregnant women, prisoners, those with metal in their body, pacemakers, certain implants, or severe claustrophobia cannot join.Check my eligibility
What is being tested?
The study tests a precise DCE-MRI technique for diagnosing brain cancer recurrence or metastases from melanoma. It also evaluates the response of these conditions to bevacizumab (for glioma) or immunotherapy (for melanoma).See study design
What are the potential side effects?
While DCE-MRI itself typically doesn't cause side effects beyond discomfort from lying still, bevacizumab can lead to hypertension, bleeding issues, wound healing complications, and proteinuria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Extracellular Space
Fractional plasma volume (vp)
Model-free initial area under the contrast agent concentration curve (iAUC)
+1 moreSide effects data
From 2013 Phase 2 trial • 44 Patients • NCT0022776011%
Dyspnea
7%
Headache
5%
Infection and infestations - other
5%
Chest pain - cardiac
5%
Back pain
5%
Dehydration
5%
Myocardial infarction
2%
Hypoxia
2%
Seizure
2%
Chest wall pain
2%
Vascular disorder - other
2%
Thromboembolic event
2%
Syncope
2%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Cediranib Maleate)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort II (STAR DCE-MRI)Experimental Treatment1 Intervention
Participants with melanoma brain metastases undergo STAR DCE-MRI at baseline and 4-6 weeks after therapy. Participants may undergo more frequent MRI if there is concern for tumor progression.
Group II: Cohort I (STAR DCE-MRI)Experimental Treatment2 Interventions
Participants with recurrent high-grade glioma undergo STAR DCE-MRI every 2 months, and just prior to and 4-6 weeks after starting bevacizumab treatment. Participants may undergo more frequent MRI if there is concern for tumor progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
2006
Completed Phase 2
~310
Bevacizumab
FDA approved
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,264 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,653 Total Patients Enrolled
Krishna Nayak, PhDPrincipal InvestigatorUniversity of Southern California
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your kidneys, liver, and blood need to be working well.Adults with confirmed melanoma and brain masses who will be treated with certain immunotherapy drugs and have a Karnofsky Performance Score higher than 60%.You cannot have an MRI if you have metal in your body, a pacemaker, certain medical devices, or if you are claustrophobic or have uncontrollable movement.You have a type of brain tumor called high-grade glioma that has come back and you have been treated with bevacizumab.You are currently receiving other cancer treatments, certain medications for epilepsy, blood thinners, or anti-angiogenesis therapy. You are pregnant or have had blood clotting issues in the past.Adults with a certain type of brain tumor that is growing and will be treated with a medication that stops blood vessel growth in the tumor, with or without other chemotherapy, and have a certain level of ability to perform daily tasks.People with melanoma that has spread to the brain and are receiving immunotherapy.You should not have metal in your body from past work or surgery, a pacemaker or certain medical devices, or have a history of being afraid of small spaces or having trouble staying still.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort II (STAR DCE-MRI)
- Group 2: Cohort I (STAR DCE-MRI)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What precedent has been established for Dynamic Contrast-Enhanced Magnetic Resonance Imaging research?
"At present, 356 clinical trials are ongoing that investigate Dynamic Contrast-Enhanced Magnetic Resonance Imaging. Of those studies, 89 have moved into the third phase of research and most originate in Nantong, Jiangsu. In total, 17517 medical sites around the world participate in these experiments."
Answered by AI
What applications does Dynamic Contrast-Enhanced Magnetic Resonance Imaging typically serve?
"Dynamic Contrast-Enhanced Magnetic Resonance Imaging is an appropriate form of treatment for malignant neoplasms, recurrent platinum sensitive primary peritoneal cancer, and stage iv epithelial ovarian cancer that has been surgically resected initially."
Answered by AI
How many individuals are taking part in this medical experiment?
"Affirmative. The details posted on clinicaltrials.gov provide evidence that the trial is still actively recruiting, having first been published in April 2021 and last edited in November 2022. 150 individuals are needed to be enrolled from one single location."
Answered by AI
Are new participants accepted into this clinical experiment at present?
"Affirmative. According to the clinicaltrials website, this research is currently seeking individuals who wish to partake in it. Launched on April 13th 2021, updated November 12 2022, and requiring 150 participants at one site, this trial has opened its doors for volunteers."
Answered by AI
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