RECRUITING

Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-09-01

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06014905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Wendy Ma

CONTACT

(415) 514-4418

Wendy.Ma@ucsf.edu

Principal Investigator

Javier Villanueva-Meyer, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: Javier Villaneuva-Meyer, MD

Javier Villanueva-Meyer, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2023-09-01

Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

Meningioma