Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma
Metabolic Imaging of Patients With Lower Grade Glioma Using Hyperpolarized 13C Pyruvate
Sponsor: GE Healthcare
This observational or N/A phase trial investigates Recurrent WHO Grade III Glioma and Recurrent World Health Organization (WHO) Grade II Glioma and is currently actively recruiting participants. GE Healthcare leads this study, which shows 11 recorded versions since 2017 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)PRIMARY OBJECTIVES: I. To assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging as a new and unique tool for making an early assessment of progression and evaluation of response to therapy in patients with lower grade glioma II. To determine whether changes in levels of hyperpolarized 13C pyruvate, lactate and bicarbonate may provide early evidence of tumor progression in patients with lower grade glioma who are being followed with surveillance scans. III. To determine whether patients with lower grade glioma who are receiving treatment exhibit a reduction in levels of hyperpolarized 13C lactate/pyruvate at follow-up compared to their baseline scan. OUTLINE: Patients will be enrolled into Cohort 2. Participants previously enrolled in Cohort 1 may enroll in Cohort 2 of study upon re-review of eligibility. COHORT 1 (CLOSED TO ENROLLMENT): Patients undergo MR imaging (MRI) and MR spectroscopic imaging (MRSI) scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. COHORT 2: Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than 1 minute and undergo MRSI scan at baseline. Patients then...
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging as a new and unique tool for making an early assessment of progression and evaluation of response to therapy in patients with lower grade glioma II. To determine whether changes in levels of hyperpolarized 13C pyruvate, lactate and bicarbonate may provide early evidence of tumor progression in patients with lower grade glioma who are being followed with surveillance scans.
III. To determine whether patients with lower grade glioma who are receiving treatment exhibit a reduction in levels of hyperpolarized 13C lactate/pyruvate at follow-up compared to their baseline scan.
OUTLINE: Patients will be enrolled into Cohort 2. Participants previously enrolled in Cohort 1 may enroll in Cohort 2 of study upon re-review of eligibility.
COHORT 1 (CLOSED TO ENROLLMENT): Patients undergo MR imaging (MRI) and MR spectroscopic imaging (MRSI) scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
COHORT 2: Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
Status Flow
Change History
11 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE1 → None
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Feb 2025 — May 2026 [monthly]
Recruiting PHASE1
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Nov 2024 — Feb 2025 [monthly]
Recruiting PHASE1
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Sep 2024 — Nov 2024 [monthly]
Recruiting PHASE1
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE1
▶ Show 6 earlier versions
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Oct 2023 — Jul 2024 [monthly]
Recruiting PHASE1
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Jan 2023 — Oct 2023 [monthly]
Recruiting PHASE1
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Feb 2022 — Jan 2023 [monthly]
Recruiting PHASE1
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Oct 2021 — Feb 2022 [monthly]
Recruiting PHASE1
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Jan 2021 — Oct 2021 [monthly]
Recruiting PHASE1
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Oct 2020 — Jan 2021 [monthly]
Recruiting PHASE1
First recorded
Jan 2017
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
This trial studies how well serial magnetic resonance (MR) imaging and MR spectroscopic imaging work in characterizing lower grade glioma. Diagnostic procedures, such as MR imaging and MR spectroscopic imaging, may detect serial changes in lower grade glioma. This study may help researchers learn more about practical ways of evaluating and standardizing treatment in patients with brain tumors.
Contact Information
- GE Healthcare
- National Cancer Institute (NCI)
- Phillips-Medisize
- Sigma-Aldrich
- Susan Chang
For direct contact, visit the study record on ClinicalTrials.gov .