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Procedure
MRE Scan for Brain Tumor Assessment
N/A
Recruiting
Led By Melissa Chen, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The lesion of concern (T2 Flair Hyperintense or contrast enhancing lesion) is > 2 cm
≥18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline
Awards & highlights
Study Summary
This trial uses magnetic resonance elastography (MRE) to estimate tissue stiffness in tissue affected by radiation treatment or tumor recurrence in patients with gliomas. MRE may help doctors more accurately diagnose the disease and/or assess the disease's response to treatment.
Who is the study for?
This trial is for patients with a history of gliomas treated with chemo and radiation, who have a lesion larger than 2 cm. Participants must understand and consent to the study. It excludes pregnant individuals, those allergic to gadolinium-based contrast agents, people with severe kidney issues or GFR <30mL/min/1.73m^2, and anyone with non-MR safe implants or conditions.Check my eligibility
What is being tested?
The trial tests Magnetic Resonance Elastography (MRE) alongside MRI to measure tissue stiffness in areas affected by radiation treatment versus recurrent tumor tissues in glioma patients. The goal is more accurate diagnoses and assessments of treatment response.See study design
What are the potential side effects?
There are generally no direct side effects from MRE or MRI as they are imaging techniques; however, there may be risks related to discomfort during the procedure or reactions to contrast agents used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain lesion is larger than 2 cm.
Select...
I am 18 years old or older.
Select...
I have had a brain tumor treated with chemo and radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean lesion stiffness
Side effects data
From 2022 Phase 3 trial • 53 Patients • NCT0003329319%
87900-Vomiting(targeted toxicity)
15%
11400-Agitation
8%
11600-Alanine aminotransferase increased
8%
16800-Bladder infection
8%
44800-Infections and infestations - Other specify
8%
58700-Nystagmus
4%
15000-Aspartate aminotransferase increased
4%
88500-White blood cell decreased
4%
15300-Ataxia
4%
33900-Fever
4%
25700-Diarrhea
4%
43100-Hypokalemia
4%
69700-Rash maculo-papular(targeted toxicity)
4%
13200-Anemia
4%
33300-Febrile neutropenia
4%
57600-Nausea(targeted toxicity)
4%
20500-Catheter related infection
4%
58300-Neutrophil count decreased
4%
41300-Hypercalcemia
4%
41400-Hyperglycemia(targeted toxicity)
4%
41600-Hyperkalemia
4%
42600-Hypoalbuminemia
4%
42700-Hypocalcemia
4%
64400-Personality change
4%
41500-Hyperhidrosis
4%
13500-Anorexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Chemotherapy, Immunoglobulin Therapy)
Arm II (Chemotherapy, Observation)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (MRE, standard of care MRI)Experimental Treatment2 Interventions
Patients undergo MRE over 10 minutes and then undergo standard of care MRI of the brain with and without contrast at baseline. Within 4 weeks after the initial MRI and MRE scans, patients may undergo standard of care biopsy to check the status of the disease. Within 48 hours after biopsy, patients undergo standard of care MRI to check the status of the disease. Patients who do not undergo biopsy undergo standard of care MRI 4-8 weeks after MRE scan to check the status of the disease.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,237 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,602 Total Patients Enrolled
Melissa Chen, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
394 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain lesion is larger than 2 cm.I am 18 years old or older.I have had a brain tumor treated with chemo and radiation.My kidney function is low, with a GFR under 30 mL/min.I am under 18 years old.I understand the study and agree to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (MRE, standard of care MRI)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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