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Also known as Hyperpolarized Bicarbonate (13C)
Hyperpolarized Bicarbonate · 1 trial · 2 indications
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...
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Hyperpolarized Bicarbonate is an investigational imaging agent being studied for use in prostate cancer. It is designed to measure tissue pH in localized prostate carcinoma using magnetic resonance imaging. The drug is in early Phase 1 clinical development and is not yet approved by the FDA.
Hyperpolarized Bicarbonate is a small molecule imaging agent that targets tissue pH in the tumor microenvironment. By measuring pH levels in prostate cancer tissue, it may help characterize the tumor's metabolic state. The drug is being evaluated in an early Phase 1 trial for localized prostate carcinoma.
Hyperpolarized Bicarbonate is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting an early Phase 1 clinical trial to evaluate the drug as an imaging agent for prostate cancer.
Hyperpolarized Bicarbonate is in early Phase 1 clinical development. It is an investigational agent and has not received FDA approval. The ongoing trial is active but not recruiting participants, and it is designed to assess the drug's use in measuring tissue pH in prostate cancer.
Hyperpolarized Bicarbonate is being studied in one clinical trial, NCT05851365, titled "Magnetic Resonance (MR) Imaging With Hyperpolarized Bicarbonate (13C) to Measure Tissue pH in Prostate Cancer." The trial is in early Phase 1, active but not recruiting, and enrolls male participants aged 18 years and older in the United States.
Yes, Hyperpolarized Bicarbonate is also known as Hyperpolarized Bicarbonate (13C). The 13C label refers to the carbon-13 isotope used in the imaging agent. This alternative name appears in the clinical trial title for the drug's prostate cancer study.