Trials / Completed
CompletedNCT03073395
Preliminary Evaluation of Uptake of [68Ga]P16-093 in Metastatic Prostate and Renal Cancer
Preliminary Investigation of Uptake in PSMA Expressing Cancer, Biodistribution and Excretion of the Novel Radio Tracer [68Ga]P16-093 by PET/CT
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Five Eleven Pharma, Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
An phase I study to evaluate the uptake of \[68Ga\]P16-093 in known or suspected metastatic prostate or renal cancer to establish the feasibility of using \[68Ga\]P16-093 to image PSMA expressing cancer. Measurement of the whole body biodistribution of \[68Ga\]P16-093 in prostate cancer patients post primary curative-intent treatment with stable PSA to generate human radiation dosimetry data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [68Ga]P16-093 | Imaging by Positron Emission Tomography after iv injection of \[68Ga\]P16-093 |
Timeline
- Start date
- 2017-07-21
- Primary completion
- 2023-10-27
- Completion
- 2023-10-27
- First posted
- 2017-03-08
- Last updated
- 2025-02-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03073395. Inclusion in this directory is not an endorsement.