At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 133 enrolled
Drug / intervention
MammoSite Radiation Therapy Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)
In Brief
A Phase 2 clinical trial evaluating MammoSite Radiation Therapy System for DCIS. Completed, enrolled 133 participants across 12 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDCIS
CountriesUnited States
CollaboratorsUniversity of Southern California
Timeline
Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2003
Primary CompletionJan 2006
First PostedJan 2008
Study CompletionApr 2011
TodayJul 2026
First PostedJan 4, 2008
Enrollment StartAug 1, 2003
Primary CompletionJan 1, 2006
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.5 years ago
Interventions
MammoSite Radiation Therapy Systemdevice
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.