NCT00586326

MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ

MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Hologic, Inc. · Industry
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Data relevant to the evaluation of the efficacy and safety of the MammoSite RTS system in providing radiation therapy to patients with DCIS will be collected. The MammoSite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).

Conditions

• DCIS

Interventions

Type	Name	Description
DEVICE	MammoSite Radiation Therapy System	The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity.

Timeline

• Start date: 2003-08-01
• Primary completion: 2006-01-01
• Completion: 2011-04-01
• First posted: 2008-01-04
• Last updated: 2012-11-06
• Results posted: 2012-10-22

Locations

12 sites across 1 country: United States