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Sponsored by: |
Virginia Commonwealth University |
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Information provided by: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00699101 |
This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes.
Condition | Intervention | Phase |
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Breast Cancer |
Device: Contura Multi-Lumen Balloon |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Bio-equivalence Study |
Official Title: | A Multi-Site Prospective, Non Randomized Study Utilizing the Conture® Multi-Lumen Balloon (MLB) Breast Brachytherapy Applicator to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetric Success, Local Tumor Control, Cosmetic Outcome, Acute and Chronic Toxicity, and Clinical Scenarios for Optimal Use |
Estimated Enrollment: | 342 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2014 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Contura Multi-Lumen Balloon
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Device: Contura Multi-Lumen Balloon
Placement of the balloon in a separate procedure using ultrasound guidance after surgery for breast cancer.
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Data collected during this study will include baseline patient demographics, information related to the time of implant, radiation therapy details, and removal of the device as well as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be collected during the patient's standard follow-up visits.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
On histologic examination, the tumor must be DCIS or invasive breast carcinoma. For patients with invasive breast cancer, an axillary staging procedure must be performed. Either:
Exclusion Criteria:
Contact: Natasha Behrmann | 949-362-4800 ext 145 | nbehrmann@senorx.com |
United States, Virginia | |
Virginia Commonwealth University | Recruiting |
Richmond, Virginia, United States, 23298-0058 | |
Contact: Douglas W. Arthur, MD 804-828-7232 DArthur@mcvh-vcu.edu | |
Contact: Diane Holdford, RN 804-828-0296 djholdfo@vcu.edu | |
Principal Investigator: Douglas W. Arthur, MD |
Study Chair: | Douglas W. Arthur, MD | Virginia Commonwealth University |
Responsible Party: | Virginia Commonwealth University ( Douglas W. Arthur, MD ) |
Study ID Numbers: | SENORX-S07-002 |
Study First Received: | June 12, 2008 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00699101 |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Conture® Brachytherapy |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |