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MRI + MRSI for Brain Tumor

Q: Is exposure to Magnetic Resonance Imaging detrimental in any way?

<p>Our internal assessment of <a href="https://www.withpower.com/clinical-trials/mri">MRI</a>'s security has given it a score of 1. This is because this particular trial only possesses limited information on the safety and efficacy of Magnetic Resonance Imaging.</p>

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

11600-Alanine aminotransferase increased

16800-Bladder infection

44800-Infections and infestations - Other specify

58700-Nystagmus

15000-Aspartate aminotransferase increased

88500-White blood cell decreased

15300-Ataxia

33900-Fever

25700-Diarrhea

43100-Hypokalemia

69700-Rash maculo-papular(targeted toxicity)

13200-Anemia

33300-Febrile neutropenia

57600-Nausea(targeted toxicity)

20500-Catheter related infection

58300-Neutrophil count decreased

41300-Hypercalcemia

41400-Hyperglycemia(targeted toxicity)

41600-Hyperkalemia

42600-Hypoalbuminemia

42700-Hypocalcemia

64400-Personality change

41500-Hyperhidrosis

13500-Anorexia

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Chemotherapy, Immunoglobulin Therapy)

Arm II (Chemotherapy, Observation)

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 Imaging

2017

Completed Phase 3

~1190

Magnetic Resonance Spectroscopic Imaging

2012

Completed Phase 1

~430

Hyperpolarized Carbon C 13 Pyruvate

2018

Completed Phase 1

~10

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Phillips-MedisizeUNKNOWN

Susan ChangLead Sponsor

4 Previous Clinical Trials

217 Total Patients Enrolled

Sigma-AldrichUNKNOWN

1 Previous Clinical Trials

65 Total Patients Enrolled

Media Library

Low Grade Glioma Clinical Trial 2023: Magnetic Resonance Imaging Highlights & Side Effects. Trial Name: NCT04540107 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is exposure to Magnetic Resonance Imaging detrimental in any way?

"Our internal assessment of MRI's security has given it a score of 1. This is because this particular trial only possesses limited information on the safety and efficacy of Magnetic Resonance Imaging."

Answered by AI

Does this research project accept participants at the current time?

"As per the data on clinicaltrials.gov, this research project is actively recruiting patients. The trial was first brought to light on November 1st, 2017 and its details were last updated in December 14th 2021."

Answered by AI

How many individuals are actively engaged in this research trial?

"Affirmative. Clinicaltrials.gov data suggests that this research trial, which was initially advertised on 1st November 2017, is currently recruiting patients. Three hundred people are required to be enrolled from one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma

Susan Chang 2017. "Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04540107.