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NCT02190279 · ClinicalTrials.gov registry record · Early Phase 1
18F-DCFBC PET/CT in Prostate Cancer
A Early Phase 1 study of Prostate Cancer and Prostatic Neoplasms, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 116
- Enrollment target
- 1
- Study location
NCT02190279: Completed Early Phase 1 study of Prostate Cancer and Prostatic Neoplasms, sponsored by National Cancer Institute (NCI).
NCT02190279 is a Early Phase 1 study of Prostate Cancer and Prostatic Neoplasms that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 116 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02190279, a Early Phase 1 study of Prostate Cancer and Prostatic Neoplasms, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 116 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered positive for prostate cancer, and each was classified as local recurrence, lymph node metastases or distant metastatic sites.
Conditions Studied
Interventions
- DRUG 18F DCFBC
- DRUG Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2014-07-12 |
| Est. Completion | 2018-01-11 |
| Phase | Early Phase 1 |
What the finished NCT02190279 record still lists
NCT02190279 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which 18F DCFBC is the first listed.
NCT02190279 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02190279 about?
NCT02190279 is a clinical study titled "18F-DCFBC PET/CT in Prostate Cancer". 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 ((...
What is the current status of trial NCT02190279?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 116 participants. The study started on 2014-07-12. Estimated completion is 2018-01-11.
What conditions does trial NCT02190279 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostatic Neoplasms.
What interventions are being tested in trial NCT02190279?
The interventions under investigation include: 18F DCFBC (DRUG), Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT) (DRUG).
Who is sponsoring clinical trial NCT02190279?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02190279 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02190279's enrollment target sits among peer trials
116 314th of 735 higher than 422 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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