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Trial Title:
Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma
NCT ID:
NCT06014905
Condition:
Meningioma
Conditions: Official terms:
Meningioma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hyperpolarized carbon C 13 pyruvate
Description:
Given Intravenously (IV)
Arm group label:
Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging
Other name:
Hyperpolarized 13C-Pyruvate
Other name:
HP C13 pyruvate
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Image (MRI)
Description:
Imaging procedure
Arm group label:
Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging
Other name:
MR
Intervention type:
Other
Intervention name:
Saline
Description:
Given IV
Arm group label:
Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging
Other name:
Saline Flush
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
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wendy Ma
Phone:
415-514-4418
Email:
Wendy.Ma@ucsf.edu
Contact backup:
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Javier Villanueva-Meyer, MD
Email:
Principal Investigator
Start date:
September 1, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Javier Villaneuva-Meyer, MD
Agency class:
Other
Collaborator:
Agency:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Agency class:
NIH
Collaborator:
Agency:
General Electric
Agency class:
Industry
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06014905
