Health TrialsbyHealthPanel

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

ConditionsRecurrent World Health Organization (WHO) Grade II GliomaRecurrent WHO Grade III GliomaWHO Grade II GliomaWHO Grade III Glioma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSusan Chang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Hyperpolarized Carbon C 13 Pyruvate

    Drug

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Magnetic Resonance Spectroscopic Imaging

    Procedure/Surgery

    Undergo MRSI

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT)Experimental treatment 2 interventions
Group B: Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 4 years
2

Peak lactate/pyruvate

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

Time frame
Up to 4 years
3

Peak bicarbonate/pyruvate

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

Time frame
Up to 4 years
4

Change in peak lactate/pyruvate between scans

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

Time frame
Baseline up to 4 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Susan Chang

Lead sponsor

University of California, San Francisco

Sponsor institution

GE Healthcare

Collaborator

Sigma-Aldrich

Collaborator

Phillips-Medisize

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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