Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

NCT06014905 | Recruiting Phase 1 DMC FDA Drug

• 5 other identifiers: 23924NCI-2023-055505R21EB030899-022P01CA118816-11A12P01CA118816-16
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Meningioma

Outcome Measures

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.

  Day of MR imaging (1 day)

Secondary Outcomes (6)

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

  Day of MR imaging (1 day)

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

  Day of MR imaging (1 day)

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

  Day of MR imaging (1 day)

• Mean of pyruvate-to-lactate

  Day of MR imaging (1 day)

• Mean of pyruvate-to-alanine

  Day of MR imaging (1 day)

Study Arms (1)

Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging

EXPERIMENTAL

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.

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

Interventions

Hyperpolarized carbon C 13 pyruvate DRUG

Given Intravenously (IV)

Also known as: Hyperpolarized 13C-Pyruvate, HP C13 pyruvate

Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging

Magnetic Resonance Image (MRI) PROCEDURE

Imaging procedure

Also known as: MR

Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging

Saline OTHER

Given IV

Also known as: Saline Flush

Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Participants cannot have contraindication to MRI examinations.
• Age \>=18 years.
• Have a life expectancy of \>12 weeks.
• Karnofsky Performance Status \> 60%.
• 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.
• Participants must sign an informed consent indicating that they are aware of the investigational nature of this study.
• Participants must sign an authorization for the release of their protected health information.

You may not qualify if:

• 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.
• Participants must be excluded from participating in the study if they are not able to comply with the study and/or follow-up procedures.

Sponsors & Collaborators

• Javier Villaneuva-Meyer, MD: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• General Electric: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Meningioma

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Javier Villanueva-Meyer, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Ma

CONTACT

(415) 514-4418; Wendy.Ma@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 28, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)