Status:
ACTIVE_NOT_RECRUITING
Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With Glioblastoma
Lead Sponsor:
Susan Chang
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Glioblastoma Multiforme (GBM)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate whether new metabolic imaging will be useful to physicians and patients with glioblastoma for making treatment decisions and seeing how well various types of t...
Detailed Description
The new metabolic imaging will use hyperpolarized 13C pyruvate, which allows for pictures of the brain that we won't be able to get with standard imaging. Hyperpolarized 13C pyruvate has not been appr...
Eligibility Criteria
Inclusion
- Cohort 1: Histologically proven newly diagnosed glioblastoma multiforme (GBM) who will undergo standard of treatment with radiation therapy (RT) and temozolomide (TMZ).
- Cohort 2: Histologically proven recurrent suspected GBM who will receive surgical resection for the recurrence.
- Cohort 3: Histologically proven recurrent suspected GBM who will undergo standard treatment for the recurrence.
- Patients must be \>/= 18 years old and with a life expectancy \> 16 weeks.
- Patients must have a Karnofsky performance status of ≥ 70.
- Patients must have adequate renal function: creatinine \< 1.5 mg/dL before imaging. These tests must be performed within 60 days prior to Hyperpolarized Imaging scan.
- Patients 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.
- Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure
- Patients 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.
- Patients 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.
- Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation.
- Patients 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 of all therapy for that disease for a minimum of 3 years.
- Patients 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.
Exclusion
- Subjects must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.
Key Trial Info
Start Date :
November 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04019002
Start Date
November 19 2019
End Date
September 30 2025
Last Update
December 4 2024
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143