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

NCT04540107 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: 161016NCI-2019-08761R01CA262630P50CA097257-22
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well serial magnetic resonance (MR) imaging and MR spectroscopic imaging work in characterizing lower grade glioma. Diagnostic procedures, such as MR imaging and MR spectroscopic imaging, may detect serial changes in lower grade glioma. This study may help researchers learn more about practical ways of evaluating and standardizing treatment in patients with brain tumors.

Conditions

Recurrent WHO Grade III Glioma; WHO Grade II Glioma; WHO Grade III Glioma; Recurrent World Health Organization (WHO) Grade II Glioma

Keywords

Glioma; Hyperpolarized Pyruvate (13C)

Outcome Measures

Primary Outcomes (5)

• Number of treatment-emergent adverse events (AEs)

  Safety evaluation for endpoint will include monitoring for the occurrence of treatment-emergent adverse events (AEs). Reported toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0. All available safety data will be used and will be analyzed using descriptive statistics.

  Up to 4 years

• Peak lactate/pyruvate

  The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported.

  Up to 4 years

• Peak bicarbonate/pyruvate

  The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported.

  Up to 4 years

• Change in peak lactate/pyruvate between scans

  The change in peak lactate/pyruvate between scans will be reported.

  Baseline up to 4 years

• Change in peak bicarbonate/pyruvate between scans

  The change in peak bicarbonate/pyruvate between scans will be reported.

  Baseline up to 4 years

Study Arms (2)

Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT)

EXPERIMENTAL

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

Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging

Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)

EXPERIMENTAL

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.

Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging

Interventions

Hyperpolarized Carbon C 13 Pyruvate DRUG

Given IV

Also known as: Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)

Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT); Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)

Magnetic Resonance Spectroscopic Imaging PROCEDURE

Undergo MRSI

Also known as: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS, MRS Imaging, MRSI, Proton Magnetic Resonance Spectroscopic Imaging

Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT); Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For patients in cohort 1: histologically proven lower grade glioma who are being followed with surveillance scans
• For patients in cohort 2: histologically proven glioma who are scheduled for treatment due to suspected residual or recurrent tumor
• Patients with a life expectancy \> 12 weeks
• Patients must have a Karnofsky performance status of \>= 60
• Patients must have adequate renal function (creatinine \< 1.5 mg/dL) before imaging. These tests must be performed within 60 days prior to the hyperpolarized imaging scan.
• Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
• Patients must not have New York Heart Association (NYHA) grade II or greater congestive heart failure
• Patients must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment
• Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information
• Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation
• Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years
• Patients must not be pregnant or breast-feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of hyperpolarized imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential

You may not qualify if:

• Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures

Sponsors & Collaborators

• Susan Chang: lead
• GE Healthcare: collaborator
• Sigma-Aldrich: collaborator
• Phillips-Medisize: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Susan M Chang, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Ma

CONTACT

877-827-3222; cancertrials@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: January 11, 2017
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)