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NCT00586326 · ClinicalTrials.gov registry record · Phase 2
MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ
A Phase 2 study, sponsored by Hologic.
- Completed
- Registry status
- Phase 2
- Development phase
- 133
- Enrollment target
NCT00586326: Completed Phase 2 study, sponsored by Hologic.
NCT00586326 is a Phase 2 study that has completed, run by Hologic. The registered enrollment target is 133 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00586326, a Phase 2 study, has completed, sponsored by Hologic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 133 participants
- Enrollment target
Study Summary
This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.
Primary Outcome
Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.
Interventions
- DEVICE MammoSite Radiation Therapy System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2003-08 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
What the finished NCT00586326 record still lists
NCT00586326 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which MammoSite Radiation Therapy System is the first listed.
NCT00586326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00586326 about?
NCT00586326 is a clinical study titled "MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ". This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.
What is the current status of trial NCT00586326?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 133 participants. The study started on 2003-08. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00586326?
The interventions under investigation include: MammoSite Radiation Therapy System (DEVICE).
Who is sponsoring clinical trial NCT00586326?
This trial is sponsored by Hologic, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00586326's enrollment target sits among peer trials
133 538th of 2000 higher than 1,462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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