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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05851365 | Magnetic Resonance (MR) Imaging With Hyperpolarized Bicarbonate (13C) to Measure Tissue pH in Prostate Cancer | EARLY_PHASE1 | ACTIVE NOT_RECRUITING | 1 | — | — | Jul 6, 2023 | Dec 31, 2027 | May 4, 2026 | 1 | United States |
The feasibility of a study will be determined by the ability to generate adequate signal to noise ratio to measure acidity (pH) in tumor or adjacent healthy tissue. This study will be considered successful if the 13C bicarbonate (CO2) and 13C-CO2 resonances in tumor or normal prostate are qualitatively detectable and signal to noise ratios are greater than 2. The point estimation and 95% confidence intervals (CI) of the participants having sufficient signal to noise ratio will be obtained using the Wilson Score confidence interval method.
| Arm | Type | Description |
|---|---|---|
| Pre-surgical participants with prostate cancer | EXPERIMENTAL | The hyperpolarized 13C bicarbonate injection includes the administration of 35 mL injected intravenously (IV) at a rate of 5 mL/second followed by a 20 mL saline flush at 5 mL/second, followed by magnetic resonance (MR) imaging. The intervention will include routine and safety assessments 5 to 9 days after the injection. |
| Name | Type | Description |
|---|---|---|
| Hyperpolarized Bicarbonate (13C) | DRUG | Given IV |
| Magnetic Resonance imaging | PROCEDURE | Magnetic resonance imaging is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body |
Inclusion Criteria: 1. Patients age \>=18 years. 2. Patients must have biopsy-proven adenocarcinoma of the prostate; biopsy may be performed outside of University of California, San Francisco (UCSF) if detailed results of sextant biopsy are available. 3. Tumor size of at least 1.0 cm in long axis o...