Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

Javier Villaneuva-Meyer, MD

Status and phase: Enrolling; Phase 1

Conditions: Meningioma

Treatments: Drug: Hyperpolarized carbon C 13 pyruvate; Other: Saline; Procedure: Magnetic Resonance Image (MRI)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06014905

2P01CA118816-16 (U.S. NIH Grant/Contract)

2P01CA118816-11A1 (U.S. NIH Grant/Contract)

23924

NCI-2023-05550 (Registry Identifier)

5R21EB030899-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

Primary Objective:

I. To assess the feasibility of hyperpolarized 13C MR imaging as a new and unique tool in the characterization of aggressive tumor behavior in participants with meningioma.

Secondary Objectives:

I. To define the most appropriate parameters for obtaining hyperpolarized 13C data from meningioma patients with a run-in study to optimize spatial and temporal resolution and coverage by detecting signal amplitudes and time dynamics.

II. To measure tumor pyruvate-to-lactate, pyruvate-to-alanine, and pyruvate-to-bicarbonate conversion by 13C pyruvate MR imaging in participants with meningioma planning to undergo surgical resection within 4 weeks, using parameters.

Outline:

Participants will receive a single imaging procedure using HP 13C pyruvate. Participants will then be followed-up for 30 days after completion of the study or until voluntary withdrawal or death.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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).

   a. Thirty of the participants plan to have surgical resection within 4 weeks

2. Participants cannot have contraindication to MRI examinations.

3. Age >=18 years.

4. Have a life expectancy of >12 weeks.

5. Karnofsky Performance Status > 60%.

6. Participants must have adequate renal function (creatinine < 1.5 mg/dL) before imaging. This test must be performed within 60 days prior to hyperpolarized imaging scan.

7. Participants must sign an informed consent indicating that they are aware of the investigational nature of this study.

8. Participants must sign an authorization for the release of their protected health information.

Exclusion criteria

1. 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.
2. Uncontrolled blood pressure (Systolic BP≥140 mmHg or diastolic BP ≥>=90 mmHg) despite an optimized regimen of antihypertensive medication.
3. 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.
4. 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.
5. Participants must be excluded from participating in the study if they are not able to comply with the study and/or follow-up procedures.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging

Experimental group

Description:

Participants will receive a single research MR imaging using HP 13C pyruvate, intravenously injected at a rate of 5 ml/second followed by a 20-ml saline flush at 5 ml/second. Safety monitoring, including vital signs and symptom monitoring will be performed for 30 minutes after dosing is completed, 1 to 3 days after dosing, and up to 30 days post scanning procedure. During the follow-up period, study personnel will obtain clinical data from the participants' medical records.

Treatment:

Procedure: Magnetic Resonance Image (MRI)

Other: Saline

Drug: Hyperpolarized carbon C 13 pyruvate