Health TrialsbyHealthPanel

Hyperpolarized Imaging in Diagnosing Participants With Glioma

ConditionGlioma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorSusan Chang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperpolarized Carbon C 13 Pyruvate

    Radiation

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Radiation Therapy

    Radiation

    Undergo radiation therapy for cancer outside of this study.

  • Chemotherapy

    Drug

    Undergo chemotherapy for cancer outside of this study.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Cohort I (Hyperpolarized C13, MRI)Experimental treatment 2 interventions
Group B: Cohort II (Hyperpolarized C13, MRI)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 24 months
2

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.

Time frame
Up to 24 months
3

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.

Time frame
Up to 4 months.

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

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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