Clinical trial · Interventional
Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With Glioblastoma
Evaluating Hyperpolarized and Proton Brain Metabolism in Patients With Glioblastoma
NCT04019002CI-TRIAL-00106574completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 13C pyruvate, to obtain dynamic metabolic imaging.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperpolarized 13C Pyruvate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1: Newly Diagnosed- Standard Treatment
- description
- This arm is for patients with histologically proven newly diagnosed glioblastoma who will undergo standard treatment with radiation therapy (RT) and temozolomide (TMZ). Patients will receive two injections of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at two time points: before receiving standard treatment with RT/TMZ and at the first post-radiation follow-up scan (8 weeks later).
- interventionNames
- Drug: Hyperpolarized 13C Pyruvate
- type
- EXPERIMENTAL
- label
- Cohort 2: Recurrent- Standard Surgical Resection
- description
- This arm is for patients with histologically proven recurrent suspected glioblastoma who will receive surgical resection for the recurrence. Patients will receive one injection of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at one time point: before surgery.
- interventionNames
- Drug: Hyperpolarized 13C Pyruvate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Subjects must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.
References
Publications (0)
Data not yet available
No reference posted for this study.