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

NCT00556907 | Terminated Results FDA Device

• 1 other identifier: 1B-06-9
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

DCIS; To evaluate Preoperative mammagraphy and MRI to select candiates with DCIS for IORT

Outcome Measures

Primary Outcomes (1)

• Reoperation (Re-excision or Mastectomy) Rates Following WLE or IORT

  These are the rates of reoperation for re-excision or mastectomy following Wide Local Excision (WLE) or Intraoperative Radiation Therapy (IORT). The number of patients who required reoperation were reported below.

  30 days

Secondary Outcomes (1)

• Number of Serious Adverse Events.

  2 years

Study Arms (1)

1

OTHER

Patients will receive IORT

Radiation: Intraoperative radiotherapy; Device: Intraoperative radiotherapy

Interventions

Intraoperative radiotherapy RADIATION

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

Also known as: Intrabeam Photon Radiosurgery System and Applicators

1

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Localized DCIS measuring less then equal to 4 cm on preoperative imaging.
• Cohort 2 (Delayed IORT group)
• Localized DCIS measuring less then equal to4 cm or less on surgical pathology
• Delayed IORT could be performed for the explicit purpose of administering IORT or performed following re-excision of a previously operated breast to achieve clear surgical margins.
• This cohort includes patients who were excluded from immediate IORT based on pre-operative imaging suggesting ineligibility for immediate IORT, but who are subsequently found to meet histological criteria (localized DCIS less then equal to 4 cm and no invasive cancer) for IORT based on surgical pathology.

You may not qualify if:

• 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
• Serious psychiatric or addictive disorders

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• Hickey BE, Lehman M. Partial breast irradiation versus whole breast radiotherapy for early breast cancer. Cochrane Database Syst Rev. 2021 Aug 30;8(8):CD007077. doi: 10.1002/14651858.CD007077.pub4.

  PMID: 34459500 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Results Point of Contact

• Title: Tali Homsey
• Organization: USC/Norris Comprehensive Cancer Center

tali.homsey@med.usc.edu

(323) 865-0451

Study Officials

• Heather Macdonald, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 12, 2007
• Study Start: October 1, 2007
• Primary Completion: March 1, 2015
• Study Completion: November 1, 2016
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Locations

US (1)