Hyperpolarized Imaging in Diagnosing Participants With Glioma

NCT03739411 | Recruiting Phase 1 DMC FDA Drug

• 5 other identifiers: 13106NCI-2018-00939R01CA109767R01CA2730282P50CA097257
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot trial studies the side effects of hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing participants with glioma. Diagnostic procedures, such as hyperpolarized carbon C 13 pyruvate MRI, may help find and diagnose glioma.

Conditions

Glioma

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events

  Adverse events will be monitored from just before investigational medicinal product (IMP) administration until the end of study participation. Vital signs (blood pressure and heart rate only) will be recorded at baseline and 30 minutes post injection. For blood pressures and heart rate recorded after IMP administration, the following safety endpoints will be summarized for each part of the study: (1) The occurrence of changes from baseline, at each post-administration time point, greater than a pre-specified magnitude (20 mm Hg for systolic blood pressure, 10 mm Hg for diastolic blood pressure, 10 beats per minute for heart rate). (2) The occurrence of post-administration values outside the normal limits. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0

  Up to 24 months

• Peak lactate/pyruvate ratio in brain tissue

  The lactate/pyruvate ratio and/or glutamate/pyruvate will be compared in tumor versus normal appearing brain tissue. Comparisons will be made using a Wilcoxon signed rank test.

  Up to 24 months

• Peak lactate/pyruvate ratio in (13C) pyruvate scan

  The lactate/pyruvate ratio and/or glutamate/pyruvate from baseline will be compared to the ratio on the post-radiation therapy (RT) repeat scan. Comparisons will be made using a Wilcoxon signed rank test.

  Up to 4 months.

Study Arms (2)

Cohort I (Hyperpolarized C13, MRI)

EXPERIMENTAL

Participants receive hyperpolarized carbon C 13 pyruvate intravenously IV and undergo MRI. The second hyperpolarized 13 C injection/imaging will be started approximately 15 to 60 minutes after the first injection for those who are willing to receive two 13 C injections

Radiation: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging

Cohort II (Hyperpolarized C13, MRI)

EXPERIMENTAL

Participants receive hyperpolarized carbon C 13 pyruvate IV and undergo MRI before treatment and 4 weeks after completion of cancer therapy given outside of this study.

Radiation: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging; Radiation: Radiation Therapy; Drug: Chemotherapy

Interventions

Hyperpolarized Carbon C 13 Pyruvate RADIATION

Given IV

Also known as: Hyperpolarized Pyruvate (13C)

Cohort I (Hyperpolarized C13, MRI); Cohort II (Hyperpolarized C13, MRI)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

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

Cohort I (Hyperpolarized C13, MRI); Cohort II (Hyperpolarized C13, MRI)

Radiation Therapy RADIATION

Undergo radiation therapy for cancer outside of this study.

Also known as: Radiotherapeutics, Radiotherapy

Cohort II (Hyperpolarized C13, MRI)

Chemotherapy DRUG

Undergo chemotherapy for cancer outside of this study.

Cohort II (Hyperpolarized C13, MRI)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Participants in Cohort 1: Histologically proven glioma who have evidence of evaluable disease based on a prior magnetic resonance (MR) scan.
• For Participants in Cohort 2: Histologically proven glioma who will be undergoing treatment.
• To be included in the study all subjects must also meet the following criteria:
• Participants must be \> 18 years old and with a life expectancy \> 12 weeks.
• Participants must have a Karnofsky performance status of ≥ 60.
• Participants must have adequate renal function (creatinine \< 1.5 mg/dL) before starting therapy. This tests must be performed within 60 days prior to Hyperpolarized Imaging scan.
• Participants 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 tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent.
• Participants must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure
• Participants must not have a history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
• Participants 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.
• Participants may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation.
• Participants must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years.
• Participants 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:

• \. Participants must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.

Sponsors & Collaborators

• Susan Chang: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (1)

• Autry AW, Gordon JW, Chen HY, LaFontaine M, Bok R, Van Criekinge M, Slater JB, Carvajal L, Villanueva-Meyer JE, Chang SM, Clarke JL, Lupo JM, Xu D, Larson PEZ, Vigneron DB, Li Y. Characterization of serial hyperpolarized 13C metabolic imaging in patients with glioma. Neuroimage Clin. 2020;27:102323. doi: 10.1016/j.nicl.2020.102323. Epub 2020 Jun 24.

  PMID: 32623139 BACKGROUND

MeSH Terms

Conditions

Glioma

Interventions

Magnetic Resonance Spectroscopy; Radiotherapy; Radiation; Drug Therapy

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; Therapeutics; Physical Phenomena

Study Officials

• Susan Chang, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Ma

CONTACT

(415) 514-4418; Wendy.Ma@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Residence and Vice Chair of Neurological Surgery

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: November 13, 2018
• Study Start: December 9, 2015
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)