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NCT00426959 · ClinicalTrials.gov registry record · Phase 1
Study of Image-guided Dosimetry for Interstitial Prostate Brachytherapy
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00426959: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT00426959 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00426959, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This will be a phase I study. This phase I study is not a standard drug dose escalation study, but rather a Clinical System Performance Evaluation Trial of a therapeutic device. However for purposes of this protocol we will refer to this portion of the trial as a phase I study. The purpose of this study is to demonstrate the feasibility and clinical practicability of the registered ultrasound and fluoroscopy (RUF) in combination with CMS Interplant system® in an initial cohort of 6 patients. This will involve demonstrating the feasibility of using the system in an actual operating room environment as well as obtaining a preliminary assessment of the accuracy and performance of the source location algorithm by comparing with postoperative CT dosimetry. The Primary endpoint of this study will be evaluation of the feasibility of using the RUF system and of performing real-time optimization in the operating room environment. The Secondary endpoints of this study will be: 1. Acute and late toxicity as assessed by IPSS, SHIM, and EPIC questionnaires at multiple follow-up intervals. 2. PSA-free survival. Study Population: The target population will be patients with a diagnosis of adenocarcinoma of the prostate who are seen in consultation at the Johns Hopkins Hospital. Approximately 360 patients per year with the diagnosis of prostate cancer are seen in the Department of Radiation Oncology at Johns Hopkins Hospital. Of these patients, approximately 45% have low-risk (T1a-T2a, Gleason 6 or less, PSA 10 ng/ml or less) or intermediate-risk disease and are suitable for brachytherapy based on disease risk. Within this group of patients, approximately 70% are eligible for brachytherapy based on gland size and no prior transurethral resection of prostate (TURP). Approximately 80% of patients offered brachytherapy at consultation decide to receive their treatment at Johns Hopkins. Overall, we currently perform 2 brachytherapy procedures per week on average, for a yearly t
Interventions
- DEVICE Image Guided Dynamic Dosimetry
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2005-02 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
What the finished NCT00426959 record still lists
NCT00426959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Image Guided Dynamic Dosimetry is the first listed.
NCT00426959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00426959 about?
NCT00426959 is a clinical study titled "Study of Image-guided Dosimetry for Interstitial Prostate Brachytherapy". This will be a phase I study. This phase I study is not a standard drug dose escalation study, but rather a Clinical System Performance Evaluation Trial of a therapeutic device. However for purposes of this protocol we will refer to this portion of the trial as a phase I study. The purpose of this ...
What is the current status of trial NCT00426959?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2005-02. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00426959?
The interventions under investigation include: Image Guided Dynamic Dosimetry (DEVICE).
Who is sponsoring clinical trial NCT00426959?
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 NCT00426959's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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