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NCT01448447 · ClinicalTrials.gov registry record · NA
Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®
A NA study, sponsored by Mercy Research.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT01448447 is a NA study that has completed, run by Mercy Research. The registered enrollment target is 20 participants.
The verdict
NCT01448447, a NA study, has completed, sponsored by Mercy Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
This study will evaluate the local control rate, cosmetic results, and complication rates of breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of radiation therapy or as a boost technique for patients with stage I-II carcinoma of the breast (\< 3 cm), (non-lobular histology) treated with lumpectomy with histologically negative surgical margins by at least 2 mm, negative axillary lymph nodes, and DCIS. Hypotheses: * For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ (DCIS), radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is technically feasible and reproducible with acceptable complication rates. * Cosmetic results after brachytherapy will be similar to that obtained after traditional whole breast external beam radiation therapy. * Local tumor control rate in the breast after brachytherapy will be similar to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.
Interventions
- DEVICE Mammosite ML
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-12 |
| Est. Completion | 2016-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01448447
The ClinicalTrials.gov registry entry for NCT01448447 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mercy Research, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mammosite ML is the first listed.
NCT01448447 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01448447 about?
NCT01448447 is a clinical study titled "Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®". This study will evaluate the local control rate, cosmetic results, and complication rates of breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of radiation therapy or as a boost technique for patients with stage I-II carcinoma of the breast (\< 3 cm), (non-lobular h...
What is the current status of trial NCT01448447?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2009-12. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01448447?
The interventions under investigation include: Mammosite ML (DEVICE).
Who is sponsoring clinical trial NCT01448447?
This trial is sponsored by Mercy Research, which has 14 total clinical trials registered on ClinicalTrials.gov.
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