CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 116 enrolled
Drug / intervention
18F DCFBC +1 moredrug
Likely dose
18F DCFBC 1 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02190279
NCT02190279Early Ph 1Completed

A Pilot Study of 18F-DCFBC PET/CT in Prostate Cancer

National Cancer Institute (NCI)·interventional·Posted Jul 15, 2014·Updated Apr 23, 2019

In Brief

A Early Phase 1 clinical trial evaluating 18F DCFBC and Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT) for Prostatic Neoplasms and Prostate Cancer. Completed, enrolled 116 participants across 1 site.

Detailed Summary

Background: \- Prostate cancer is the second leading cause of cancer deaths in American men. A chemical called a radiotracer helps doctors get images of this type of cancer. Researchers want to test a radiotracer called N-\[N-\[(S)-1,3-dicarboxypropyl\]carbamoyl\]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC). Objective: \- To see if the radiotracer 18F-DCFBC can identify sites of prostate cancer in the body. Eligibility: \- Men ages 18 and over with prostate cancer. The cancer must be newly diagnosed, have relapsed, or has spread outside the prostate. Design: * Participants will be screened with physical exam and medical history. They will give a blood sample. * Participants will be divided into three groups. Group 1: people with cancer only in the prostate scheduled for surgical prostate removal or biopsy at National Institutes of Health (NIH). Group 2: people who had their prostate removed or had radiation therapy and now have a rising prostate-specific antigen (PSA) without other signs of disease. Group 3: people whose cancer has spread to other areas of the body. * Participants will have 18F-DCFBC injected into a vein then imaged in a positron emission tomography (PET)/computed tomography (CT) camera. During the scans, they will lie on their back on the scanner table. * Group 1 will have a magnetic resonance imaging (MRI) scan. A tube will be placed in the rectum. Coils may be wrapped around the outside of the pelvis. Participants will have a contrast agent injected through an intravenous line. * Group 3 will have another PET/CT scan with a different radiotracer, 18F NaF, within 21 days of the 18F-DCFBC scan to look for prostate cancer in the bone. * Group 3 will repeat the two PET/CT scans 4-6 months after the initial scans. * A few days after each scan, participants will be contacted for follow-up.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 15, 2014
Enrollment StartJul 12, 2014
Primary CompletionDec 31, 2017
Study CompletionJan 11, 2018
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 12.0 years ago

Interventions

18F DCFBCdrug

Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT)drug