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Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer

NCT03444844 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-05-02

No results posted yet for this study

Summary

Initial performance of Ga-68-P16-093 in prostate cancer patients including dosimetry and preliminary efficacy evaluation in BCR patients, and correlation of Ga-68-P16-093 uptake with tissue histopathology in intermediate to high risk primary prostate cancer patients.

Conditions

Interventions

DRUG

Ga-68 P16-093 PET/CT scan

IV injection followed by PET/CT scanning

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • Five Eleven Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Green, PhD · Indiana University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-10
Primary Completion
2020-10-27
Completion
2022-07-31
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 NCT03444844 on ClinicalTrials.gov