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

Part of paid clinical trials in San Francisco, California.

Sponsor
Susan Chang
Study ID
NCT04540107
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyperpolarized Carbon C 13 Pyruvate — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Magnetic Resonance Spectroscopic Imaging — PROCEDURE
    Undergo MRSI

Study Details

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.

Key Dates

Start date
Jan 11, 2017
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT)
    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
  • Experimental: Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)
    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.

Primary Outcome Measure

Number of treatment-emergent adverse events (AEs) [ Time Frame: Up to 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Wendy Ma
[email protected]
877-827-3222
Susan M. Chang, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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