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

NCT00586326 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2012-11-06

Study results available
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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.

Conditions

  • DCIS

Interventions

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.

Sponsors & Collaborators

  • University of Southern California

    collaborator OTHER

  • Hologic, Inc.

    lead INDUSTRY

Principal Investigators

  • Oscar Streeter, MD · University of Southern California

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2006-01-31
Completion
2011-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00586326 on ClinicalTrials.gov