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Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast

NCT00556907 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-11-06

Study results available
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Summary

We hypothesize that the combination of mammography and CE-MRI will improve the surgeon and radiologist's ability to define extent of disease prior to surgical resection, improve the odds of obtaining clear surgical margins, and increase the efficacy of IORT delivered immediately after initial surgical resection. In this investigation, we will determine whether or not patients deemed eligible for 'immediate" IORT based on mammography and CE-MRI can be successfully treated without the need for re-excision or additional radiotherapy due to inadequate surgical margins.

Conditions

Interventions

RADIATION

Intraoperative radiotherapy

20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed

DEVICE

Intraoperative radiotherapy

20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Heather Macdonald, MD · University of Southern California

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2015-03-31
Completion
2016-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT00556907 on ClinicalTrials.gov