Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04540107 | Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma | PHASE1 | RECRUITING | 300 | — | — | Jan 11, 2017 | Jan 31, 2027 | Apr 29, 2026 | 1 | United States |
Safety evaluation for endpoint will include monitoring for the occurrence of treatment-emergent adverse events (AEs). Reported toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0. All available safety data will be used and will be analyzed using descriptive statistics.
The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported.
The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported.
The change in peak lactate/pyruvate between scans will be reported.
The change in peak bicarbonate/pyruvate between scans will be reported.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT) | EXPERIMENTAL | Patients undergo MRI and 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. Participants enrolled in cohort 1 may later enroll in cohort 2 of study once eligibility has been reviewed and approved by neuro-oncologist |
| Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI) | EXPERIMENTAL | Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate 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. |
| Name | Type | Description |
|---|---|---|
| Hyperpolarized Carbon C 13 Pyruvate | DRUG | Given IV |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI |
| Magnetic Resonance Spectroscopic Imaging | PROCEDURE | Undergo MRSI |
Inclusion Criteria: * For patients in cohort 1: histologically proven lower grade glioma who are being followed with surveillance scans * For patients in cohort 2: histologically proven glioma who are scheduled for treatment due to suspected residual or recurrent tumor * Patients with a life expect...