A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057
NCT02916537 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2017-11-06
Summary
The purpose of this study is to test a novel diagnostic Positron Emission Tomography (PET) imaging agent for safety and biodistribution. The agent binds Prostate Specific Membrane Antigen (PSMA) and is designed to detect prostate tumors.
Conditions
Interventions
- DRUG
-
CTT1057
Single IV dose (370 MBq, or 10 mCi) of CTT1057 followed by combined PET/MR imaging (prostate + whole body).
- PROCEDURE
-
Prostatectomy
Radical prostatectomy with lymph node dissection
Sponsors & Collaborators
-
University of California, San Francisco
collaborator OTHER -
Cancer Targeted Technology
lead INDUSTRY
Principal Investigators
-
Beatrice Langton-Webster, PhD · Cancer Targeted Technology
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-30
- Primary Completion
- 2017-08-28
- Completion
- 2017-08-28
Countries
- United States
Study Locations
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