Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

Meningioma Clinical Trial

Official title:

Pilot/Phase I Study of Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014905
• Other study ID #: 23924
• Secondary ID: NCI-2023-055505R
• Status: Recruiting
• Phase: Phase 1
• Start date: September 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: Wendy Ma
• Phone: (415) 514-4418
• Email: Wendy.Ma[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

2. Participants cannot have contraindication to MRI examinations.

3. Age >=18 years.

4. Have a life expectancy of >12 weeks.

5. Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >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. Patients 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. Has New York Heart Association (NYHA) Grade II or greater congestive heart failure.

3. Has history of myocardial infarction or unstable angina within 12 months prior to study enrollment.

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

5. 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.

6. 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.

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

Related Conditions & MeSH terms

• Meningioma

Intervention

Drug:
• Hyperpolarized carbon C 13 pyruvate
Given Intravenously (IV)

Procedure:
• Magnetic Resonance Image (MRI)
Imaging procedure

Other:
• Saline
Given IV

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Javier Villaneuva-Meyer, MD	General Electric, National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day of MR imaging (1 day)
Secondary	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.	Day of MR imaging (1 day)
Secondary	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.	Day of MR imaging (1 day)
Secondary	Mean of pyruvate-to-lactate	The mean and standard deviations of pyruvate-to-lactate ratio will be reported.	Day of MR imaging (1 day)
Secondary	Mean of pyruvate-to-alanine	The mean and standard deviations of pyruvate-to-alanine ratio will be reported.	Day of MR imaging (1 day)
Secondary	Mean of pyruvate-to-bicarbonate conversion	The mean and standard deviations of pyruvate-to-bicarbonate conversion rate will be reported.	Day of MR imaging (1 day)