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Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

ConditionMeningioma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharlie Wang, MD, PhD

About this trial

This is a Pilot/Phase I clinical study of hyperpolarized 13C (HP 13C) pyruvate injection that includes the acquisition of magnetic resonance (MR) data performed on participants with meningioma to evaluate metabolism and aid in the non-invasive characterization of aggressive tumor behavior

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Known (histopathologically confirmed) or presumed meningioma based on imaging with measurable disease on MRI that shows gadolinium enhancement (at least one cm diameter) intracranially (e.g., not confined to skull base alone).

Participants cannot have contraindication to MRI examinations.

Age >=18 years.

Have a life expectancy of >12 weeks.

Disqualifiers

Has 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.

Uncontrolled blood pressure (Systolic BP≥140 mmHg or diastolic BP ≥>=90 mmHg) despite an optimized regimen of antihypertensive medication.

Has a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of 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 participants of child-bearing potential.

Trial design

Design model

Single group

Treatments tested in this trial

  • Hyperpolarized carbon C 13 pyruvate

    Drug

    Given Intravenously (IV)

  • Magnetic Resonance Image (MRI)

    Procedure/Surgery

    Imaging procedure

  • Saline

    Other intervention

    Given IV

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Hyperpolarized 13C pyruvate, Magnetic Resonance ImagingExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Proportion of participants who complete 13C pyruvate MR imaging.

All participants who are enrolled in the study and receive any amount of hyperpolarized 13C pyruvate will be included in the primary outcome analysis. The proportion of participants who complete hyperpolarized 13C pyruvate MR imaging will be reported. If the proportion is greater than 0.7, hyperpolarized 13C MR imaging will be determined to be feasible.

Time frame
Day of MR imaging (1 day)

Secondary outcomes

1

Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-lactate cell metabolism

Five initial patients will be evaluated to establish the spatial and temporal resolution and coverage that yields the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-lactate will be identified.

Time frame
Day of MR imaging (1 day)
2

Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-alanine cell metabolism

Five initial patients will be evaluated to establish the spatial, temporal resolution and coverage that yield the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-alanine will be identified.

Time frame
Day of MR imaging (1 day)
3

Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-bicarbonate cell conversion

Five initial patients will be evaluated to establish the spatial and temporal resolution and coverage that yield the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-bicarbonate conversion will be identified.

Time frame
Day of MR imaging (1 day)
4

Mean of pyruvate-to-lactate

The mean and standard deviations of pyruvate-to-lactate ratio will be reported.

Time frame
Day of MR imaging (1 day)

Other outcomes

Sponsors and contacts

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

Charlie Wang, MD, PhD

Lead sponsor

University of California, San Francisco

Sponsor institution

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

General Electric

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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