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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

Must not have

Renal failure as evidenced by a glomerular filtration rate (GFR) of less than 30 mL/min/1.73m2

Patients less than 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My brain lesion is larger than 2 cm.

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I am 18 years old or older.

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I have had a brain tumor treated with chemo and radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is low, with a GFR under 30 mL/min.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean lesion stiffness

Side effects data

From 2022 Phase 3 trial • 53 Patients • NCT00033293

19%

87900-Vomiting(targeted toxicity)

15%

11400-Agitation

58700-Nystagmus

16800-Bladder infection

11600-Alanine aminotransferase increased

44800-Infections and infestations - Other specify

58300-Neutrophil count decreased

41400-Hyperglycemia(targeted toxicity)

69700-Rash maculo-papular(targeted toxicity)

33900-Fever

33300-Febrile neutropenia

20500-Catheter related infection

42600-Hypoalbuminemia

43100-Hypokalemia

88500-White blood cell decreased

41300-Hypercalcemia

42700-Hypocalcemia

15300-Ataxia

64400-Personality change

13200-Anemia

57600-Nausea(targeted toxicity)

13500-Anorexia

15000-Aspartate aminotransferase increased

25700-Diarrhea

41600-Hyperkalemia

41500-Hyperhidrosis

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Chemotherapy, Immunoglobulin Therapy)

Arm II (Chemotherapy, Observation)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1160

0 / 5Eligibility criteria met