deltatrials
Recruiting INTERVENTIONAL NCT04540107

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

Updated 11 times since 2020 Last updated: Apr 27, 2026 Started: Jan 11, 2017 Primary completion: Jan 31, 2027 Completion: Jan 31, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshotRecruiting~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotRecruiting~Oct 2021 – ~Feb 2022 · 4 months · monthly snapshotRecruiting~Feb 2022 – ~Jan 2023 · 11 months · monthly snapshotRecruiting~Jan 2023 – ~Oct 2023 · 9 months · monthly snapshotRecruiting~Oct 2023 – ~Jul 2024 · 9 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshotRecruiting~Nov 2024 – ~Feb 2025 · 3 months · monthly snapshotRecruiting~Feb 2025 – ~May 2026 · 15 months · monthly snapshotRecruitingMay 4, 2026 – present · 3 months · daily APIRecruiting

Change History

11 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: PHASE1None

  2. Feb 2025 — May 2026 [monthly]

    Recruiting PHASE1

  3. Nov 2024 — Feb 2025 [monthly]

    Recruiting PHASE1

  4. Sep 2024 — Nov 2024 [monthly]

    Recruiting PHASE1

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1

Show 6 earlier versions
  1. Oct 2023 — Jul 2024 [monthly]

    Recruiting PHASE1

  2. Jan 2023 — Oct 2023 [monthly]

    Recruiting PHASE1

  3. Feb 2022 — Jan 2023 [monthly]

    Recruiting PHASE1

  4. Oct 2021 — Feb 2022 [monthly]

    Recruiting PHASE1

  5. Jan 2021 — Oct 2021 [monthly]

    Recruiting PHASE1

  6. 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

Sponsor contact:
  • GE Healthcare
  • National Cancer Institute (NCI)
  • Phillips-Medisize
  • Sigma-Aldrich
  • Susan Chang
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations