NCT04019002
Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With Glioblastoma
Free. We email you which fields changed when ClinicalTrials.gov updates this record.
Record History
All 13 versions: 10 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗
Notable Reclassified as terminated (was completed) Sponsor's reason: Slow Accrual Show 5 more changesShow less
- Results posted: Oct 27, 2026
- Primary endpoints: 12 to 4
- Interventions: Hyperpolarized 13C Pyruvate (Drug) to Hyperpolarized Pyruvate (13C) (Drug), Magnetic Resonance Spectroscopic Imaging (MRSI) (Procedure)
- Eligibility criteria expanded, about 15 words
- Study description expanded, about 104 words
- Minor Trial status: Active, Not Recruiting to Completedv12
- Notable Primary and study completion dates: Jan 28, 2025 to Sep 30, 2025
- Trial status: Recruiting to Active, Not Recruiting
- Enrollment target: estimated 90 to confirmed 17
- Site details revised
- Notable Primary and study completion dates: Feb 28, 2023 to Jan 28, 2025v9
- Minor Eligibility criteria shortened, about 1 wordv7
Show 4 earlier versionsHide 4 earlier versions
- Notable Primary and study completion dates: Mar 1, 2022 to Feb 28, 2023
- Site contact updated
- Notable Primary and study completion dates: Mar 2021 to Mar 1, 2022
- Start date: Oct 8, 2019 to Nov 19, 2019
- Eligibility criteria shortened, about 42 words
- Notable Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Oct 2019 to Oct 8, 2019
- Site details revised
- Notable Start date: Aug 2019 to Oct 2019v3
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Arms and interventions
This arm is for participants with histologically proven newly diagnosed glioblastoma who will undergo non-investigational treatment with radiation therapy (RT) and temozolomide (TMZ). Participants 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 (4-8 weeks later).
This arm is for participants with histologically proven recurrent suspected glioblastoma who will receive surgical resection for the recurrence. Participants 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.
This arm is for participants with histologically proven recurrent suspected who will undergo standard treatment for the recurrence. Participants will receive two injections of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at three time points: prior to treatment (baseline), approximately 7-14 days after the initiation of treatment, and 6-8 weeks after the initiation of treatment.
Drugs: Hyperpolarized Pyruvate (13C)
Procedures: Magnetic Resonance Spectroscopic Imaging (MRSI)
Sites
1 site in 1 country
- University of California, San FranciscoSan Francisco, California, United States