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Preliminary Evaluation of Uptake of [68Ga]P16-093 in Metastatic Prostate and Renal Cancer

NCT03073395 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-26

No results posted yet for this study

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

DRUG

[68Ga]P16-093

Imaging by Positron Emission Tomography after iv injection of \[68Ga\]P16-093

Sponsors & Collaborators

  • Five Eleven Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-21
Primary Completion
2023-10-27
Completion
2023-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03073395 on ClinicalTrials.gov