Pilot Study of Safety and Feasibility of Acquiring Hyperpolarized Imaging in Patients With Gliomas

Who is this study for? Patients with Glioma
What treatments are being studied? Hyperpolarized Carbon C 13 Pyruvate+Magnetic Resonance Imaging
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Radiation, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This pilot trial studies the side effects of hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing participants with glioma. Diagnostic procedures, such as hyperpolarized carbon C 13 pyruvate MRI, may help find and diagnose glioma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

‣ For Participants in Cohort 1: Histologically proven glioma who have evidence of evaluable disease based on a prior magnetic resonance (MR) scan.

‣ For Participants in Cohort 2: Histologically proven glioma who will be undergoing treatment.

‣ To be included in the study all subjects must also meet the following criteria:

• Participants must be \> 18 years old and with a life expectancy \> 12 weeks.

• Participants must have a Karnofsky performance status of ≥ 60.

• Participants must have adequate renal function (creatinine \< 1.5 mg/dL) before starting therapy. This tests must be performed within 60 days prior to Hyperpolarized Imaging scan.

• Participants must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent.

• Participants must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure

• Participants must not have a history of myocardial infarction or unstable angina within 12 months prior to study enrollment.

• This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race.

• 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.

• Participants may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation.

⁃ Participants must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off 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 subjects of child-bearing potential.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Wendy Ma
Wendy.Ma@ucsf.edu
(415) 514-4418
Time Frame
Start Date: 2015-12-09
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 140
Treatments
Experimental: Cohort I (Hyperpolarized C13, MRI)
Participants receive hyperpolarized carbon C 13 pyruvate intravenously IV and undergo MRI. The second hyperpolarized 13 C injection/imaging will be started approximately 15 to 60 minutes after the first injection for those who are willing to receive two 13 C injections
Experimental: Cohort II (Hyperpolarized C13, MRI)
Participants receive hyperpolarized carbon C 13 pyruvate IV and undergo MRI before treatment and 4 weeks after completion of cancer therapy given outside of this study.
Authors
Susan M. Chang
Related Therapeutic Areas
Sponsors
Leads: Susan Chang
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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