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MRI + MRSI for Brain Tumor

Phase 1

Recruiting

Led By Susan M Chang, MD

Research Sponsored by Susan Chang

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must not have New York Heart Association (NYHA) grade II or greater congestive heart failure

Patients must have a Karnofsky performance status of > 60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well MR imaging and MR spectroscopic imaging work in detecting changes in lower grade gliomas. The results may help researchers learn more about practical ways of evaluating and treating patients with brain tumors.

Who is the study for?

This trial is for adults with lower grade glioma who are either being monitored or scheduled for treatment due to tumor recurrence. They must have a life expectancy over 12 weeks, be in good physical condition (Karnofsky score >60), not have severe heart issues, HIV, other cancers (except certain skin cancers/cervical carcinoma in-situ), and no major uncontrolled illnesses. Pregnant/breastfeeding women are excluded; others must use effective contraception.

What is being tested?

The study tests how well serial MR imaging and MR spectroscopic imaging can track changes in lower grade gliomas over time. It aims to improve the evaluation of brain tumors and standardize treatments by using these advanced diagnostic procedures.

What are the potential side effects?

While the trial primarily involves diagnostic imaging techniques that are generally safe, potential side effects may include discomfort during the MRI procedure, reactions to contrast agents if used (like mild allergic reactions or kidney function impairment), and anxiety or claustrophobia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart functions well and I do not have severe heart failure.

Select...

I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in peak bicarbonate/pyruvate between scans

Change in peak lactate/pyruvate between scans

Number of treatment-emergent adverse events (AEs)

+2 more

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

69700-Rash maculo-papular(targeted toxicity)

41400-Hyperglycemia(targeted toxicity)

58300-Neutrophil count decreased

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

2Treatment groups

Experimental Treatment

Group I: Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)Experimental Treatment3 Interventions

Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate IV over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.

Group II: Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT)Experimental Treatment2 Interventions

Patients undergo MRI and MRSI scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. Participants enrolled in cohort 1 may later enroll in cohort 2 of study once eligibility has been reviewed and approved by neuro-oncologist

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Spectroscopic Imaging

2012

Completed Phase 1

~430

Hyperpolarized Carbon C 13 Pyruvate

2018

Completed Phase 1

~10