NCT04019002TerminatedPhase 1
Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With Glioblastoma
Evaluating Hyperpolarized and Proton Brain Metabolism in Patients With Glioblastoma
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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 treatment work. The goal is to improve the way patient care is managed in the future. If you chose to be in this study, you will be receiving novel magnetic resonance (MR) metabolic imaging with standard MR imaging. The research component includes an injection of an investigational agent, called hyperpolarized pyruvate 13C, to obtain dynamic metabolic imaging.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 11 Jul 2019
- Start date
- 19 Nov 2019
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Susan Chang
- Diseases
- Glioblastoma
- NCT number
- NCT04019002
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Subjects must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.