Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hyperpolarized Pyruvate · 1 trial · 1 indication
Assessment of the occurrence of clinically significant changes in safety variables from baseline. Safety endpoints include monitoring for the occurrence of treatment-emergent AEs. Monitoring will occur to evaluate for dose-limiting toxicity. Dose-Limiting Toxicity (DLT) is defined as any toxicity greater than or equal to grade 2, 3 or 4, attributable to the imaging agent and occurring within 7 days after administration. The maximum tolerated dose will be the dose level at which \<33% DLT occurs.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 0.14 ml/kg bw - hyperpolarized pyruvate |
| 2 | EXPERIMENTAL | 0.28 ml/kg bw - hyperpolarized pyruvate |
| 3 | EXPERIMENTAL | 0.43 ml/kg bw - hyperpolarized pyruvate |
| Name | Type | Description |
|---|---|---|
| Hyperpolarized Pyruvate (13C) injection | DRUG | single hyperpolarized pyruvate IV (intravenous) injection followed by MR imaging scans (MRI and MRSI) |
INCLUSION CRITERIA: 1. The subject has biopsy-proven prostate cancer and is either undergoing active surveillance ("watchful waiting") or pre primary local treatment for prostate cancer (i.e., prior to either radiation therapy or radical prostatectomy). 2. The subject is able and willing to comply ...
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Hyperpolarized Pyruvate is an investigational small molecule being studied for use in prostate cancer. It is a diagnostic imaging agent designed to visualize metabolic activity in prostate tumors. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Hyperpolarized Pyruvate is a small molecule that is hyperpolarized to enhance its signal in magnetic resonance imaging. It is used to detect metabolic changes in prostate cancer cells, specifically the conversion of pyruvate to lactate, which is elevated in tumors. This allows for non-invasive visualization of tumor metabolism.
Hyperpolarized Pyruvate is being developed by GE HealthCare Technologies Inc., a company traded on the New York Stock Exchange under the ticker symbol GEHC. The company is conducting clinical research to evaluate the drug's safety and efficacy in prostate cancer patients.
Hyperpolarized Pyruvate is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical evaluation for prostate cancer.
Hyperpolarized Pyruvate has one completed clinical trial, NCT01229618, titled 'Hyperpolarized Pyruvate Injection in Subjects With Prostate Cancer.' This Phase 1 study enrolled 31 male participants aged 18 years and older in the United States. The trial was controlled but not randomized or double-blinded, and it used a biomarker-selected approach.
Hyperpolarized Pyruvate is a specialized formulation of pyruvate, a naturally occurring molecule involved in cellular metabolism. The 'hyperpolarized' designation refers to a technique that enhances its signal in magnetic resonance imaging, allowing for real-time visualization of metabolic processes. It is not the same as standard pyruvate supplements.