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NCT01417182 · ClinicalTrials.gov registry record · Phase 1
Biodistribution and Pharmacokinetic Study of 18F-DCFBC Prostate Specific Membrane Antigen Based PET in Patients With Advanced Prostate Cancer
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01417182: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01417182 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01417182, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Prostate cancer is the most common cancer among men in the United States. Through early detection and improved local therapies a large number of men will be cured. The clinical needs include early detection, accurate initial staging and detection of local recurrence or metastases in order to permit application of the most appropriate therapy. Therapeutic monitoring and prognostic assessment are equally important. Imaging can play an important and crucial role in meeting these clinical needs. Positron emission tomography (PET) imaging has gained an important role in the clinical management of cancer patients. 18F-DCFBC is a novel low molecular weight prostate specific membrane antigen (PSMA)-based radiopharmaceutical which is radiolabeled with a fluorine-18 positron emitter for PET imaging. Preclinical mouse prostate cancer tumor model imaging studies of 18F-DCFBC demonstrate high specific uptake in PSMA expressing prostate cancer cells. The investigators will assess the hypothesis that 18F-DCFBC, a new positron emission tomography (PET) radiopharmaceutical may possess pharmacokinetic and pharmacodynamic properties that will represent an advance in imaging prostate cancer. This initial phase I study will determine the biodistribution, pharmacokinetics, and prostate specific tumor uptake in patients with metastatic prostate cancer.
Primary Outcome
Time-activity curves (TACs) demonstrating radiotracer activity as a function of time post injection (minutes) will be drawn for the whole body and the following organs: brain, breast, gallbladder, stomach, pancreas, heart wall, lung, liver, bladder, muscle, pancreas, red marrow, spleen, adrenals, upper large intestine, lower large intestine, small intestine, thymus, thyroid, testes and ovaries.Organ specific mean radiation-absorbed dose estimates for 18F-DCFBC will be calculated from the individ
Interventions
- DRUG 18F-DCFBC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
What the finished NCT01417182 record still lists
NCT01417182 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which 18F-DCFBC is the first listed.
NCT01417182 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01417182 about?
NCT01417182 is a clinical study titled "Biodistribution and Pharmacokinetic Study of 18F-DCFBC Prostate Specific Membrane Antigen Based PET in Patients With Advanced Prostate Cancer". Prostate cancer is the most common cancer among men in the United States. Through early detection and improved local therapies a large number of men will be cured. The clinical needs include early detection, accurate initial staging and detection of local recurrence or metastases in order to permit ...
What is the current status of trial NCT01417182?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-09. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01417182?
The interventions under investigation include: 18F-DCFBC (DRUG).
Who is sponsoring clinical trial NCT01417182?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01417182's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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