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Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast | Clinical Trials | Clareo Health

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

Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast (TARGIT-DCIS Trial): Use of Mammography and Breast MRI to Identify Candidates for IORT.

NCT00556907•University of Southern California

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Patients with biopsy-proven DCIS, mammographic and CE-MRI evidence of DCIS measuring great then equal to 4cm, and a desire to receive breast conserving therapy, will be considered for participation in this study.
•Patient history, physical examination findings, and demographics (sex, age, height, weight, bra size, etc.) will be performed and documented.
•All cohorts
•Signed informed consent and HIPAA documents
•Female sex
•Age great then equal to 40 years
•Localized ductal carcinoma in situ
•Clinically and/or histologically negative axillary lymph nodes
•No imaging or clinical findings suggestive of invasive carcinoma.
•Cohort 1 (Immediate IORT group)
+11 more criteria

Exclusion Criteria

•Male sex
•Age less than 40
•DCIS associated with any evidence of microinvasion or invasive carcinoma on pre-operative imaging or core biopsy of the breast or axillary nodes.
•DCIS that is multicentric in the ipsilateral breast. Multicentricity will be defined at 2 or more lesions separated by more than 3 cm in the same breast.
•Non-epithelial breast malignancies such as sarcoma or lymphoma
•DCIS associated with diffuse suspicious or indeterminate microcalcifications
•Pregnancy or lactation
•Collagen vascular diseases, including Systemic lupus erythematosus, Systemic sclerosis (scleroderma), CREST Syndrome (calcinosis, Raynaud phenomenon, esophageal dysfunction, sclerodactyly, telangiectasia, and the presence of anticentromere antibodies), polymyositis, dermatomyositis with a CPK level above normal or with an active skin rash, inclusion-body myositis, or amyloidosis
•Serious psychiatric or addictive disorders

Locations (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Key Dates

Start Date

October 1, 2007

Primary Completion Date

March 1, 2015

Completion Date

November 1, 2016

Last Updated

November 6, 2025

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

Intraoperative radiotherapy

RADIATION

Intraoperative radiotherapy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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