Back to resultsFeasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma
Primary Purpose
Meningioma
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized carbon C 13 pyruvate
Magnetic Resonance Image (MRI)
Saline
Sponsored by
About this trial
This is an interventional diagnostic trial for Meningioma
Eligibility Criteria
Inclusion Criteria: 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. Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >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. Patients must sign an authorization for the release of their protected health information. Exclusion Criteria: 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. Has New York Heart Association (NYHA) Grade II or greater congestive heart failure. Has history of myocardial infarction or unstable angina within 12 months prior to study enrollment. 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.
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Mean of pyruvate-to-lactate
The mean and standard deviations of pyruvate-to-lactate ratio will be reported.
Mean of pyruvate-to-alanine
The mean and standard deviations of pyruvate-to-alanine ratio will be reported.
Mean of pyruvate-to-bicarbonate conversion
The mean and standard deviations of pyruvate-to-bicarbonate conversion rate will be reported.
Full Information
NCT ID
NCT06014905
First Posted
August 11, 2023
Last Updated
August 23, 2023
Sponsor
Javier Villaneuva-Meyer, MD
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB), General Electric
1. Study Identification
Unique Protocol Identification Number
NCT06014905
Brief Title
Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma
Official Title
Pilot/Phase I Study of Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Javier Villaneuva-Meyer, MD
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB), General Electric
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningioma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized carbon C 13 pyruvate
Other Intervention Name(s)
Hyperpolarized 13C-Pyruvate, HP C13 pyruvate
Intervention Description
Given Intravenously (IV)
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Image (MRI)
Other Intervention Name(s)
MR
Intervention Description
Imaging procedure
Intervention Type
Other
Intervention Name(s)
Saline
Other Intervention Name(s)
Saline Flush
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Proportion of participants who complete 13C pyruvate MR imaging.
Description
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 Outcome Measure Information:
Title
Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-lactate cell metabolism
Description
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)
Title
Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-alanine cell metabolism
Description
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)
Title
Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-bicarbonate cell conversion
Description
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)
Title
Mean of pyruvate-to-lactate
Description
The mean and standard deviations of pyruvate-to-lactate ratio will be reported.
Time Frame
Day of MR imaging (1 day)
Title
Mean of pyruvate-to-alanine
Description
The mean and standard deviations of pyruvate-to-alanine ratio will be reported.
Time Frame
Day of MR imaging (1 day)
Title
Mean of pyruvate-to-bicarbonate conversion
Description
The mean and standard deviations of pyruvate-to-bicarbonate conversion rate will be reported.
Time Frame
Day of MR imaging (1 day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >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.
Patients must sign an authorization for the release of their protected health information.
Exclusion Criteria:
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.
Has New York Heart Association (NYHA) Grade II or greater congestive heart failure.
Has history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Ma
Phone
(415) 514-4418
Email
Wendy.Ma@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Villanueva-Meyer, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Ma
Phone
415-514-4418
Email
Wendy.Ma@ucsf.edu
Phone
877-827-3222
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Javier Villanueva-Meyer, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma
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