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MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)

NCT00586326•Hologic, Inc.

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.

Detailed Description

Data relevant to the evaluation of the efficacy and safety of the MammoSite RTS system in providing radiation therapy to patients with DCIS will be collected. The MammoSite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).

Eligibility

Age

45 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Pre-Surgery:
•* Unicentric pure DCIS
•* Lesions should have a greatest dimension of 3 cm or less as determined by pre-surgery mammography and MRI
•Post-Surgery:
•* Negative histological margins confirmed prior to beginning radiation therapy.
•* Margins are positive if there is tumor at the inked margin.
•* Classified as low (NG1), intermediate (NG2) or high (NG3) nuclear grade DCIS, using the Philadelphia Consensus Conference Guidelines are eligible
•* Clinically node negative

Exclusion Criteria

•Distance from the balloon surface to the surface of the skin \< 5mm as determined by CT imaging.
•Distant metastases.
•Invasive or in-situ lobular carcinoma (post-surgery assessment).
•Nonepithelial breast malignancies such as sarcoma or lymphoma.
•DCIS that is multicentric in the ipsilateral breast.
•Pregnant or lactating.
•Prior non-hormonal therapy for the present breast cancer, including radiation therapy and/or chemotherapy.
•Collagen vascular diseases
•Coexisting medical conditions with life expectancy \< 2 years.
•Serious psychiatric or addictive disorder
+4 more criteria

Locations (12)

Arizona Oncology Services

Phoenix, Arizona, United States

Daniel Freeman Hospital

Inglewood, California, United States

University of Southern California

Los Angeles, California, United States

Cedars Medical Center

Miami Beach, Florida, United States

St. Agnes Hospital

Baltimore, Maryland, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

NY Presbyterian

New York, New York, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

MD Anderson Cancer Clinic

Houston, Texas, United States

Key Dates

Start Date

August 1, 2003

Primary Completion Date

January 1, 2006

Completion Date

April 1, 2011

Last Updated

November 6, 2012

Enrollment

133

ACTUAL participants

Conditions

DCIS

Interventions

MammoSite Radiation Therapy System

DEVICE

Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)

NCT04797299

DCIS

View study

RECRUITINGPHASE2

Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer

NCT04084730

Invasive Ductal Breast CarcinomaInvasive Ductal Carcinoma, Breast+4 more

View study

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, 2012Data 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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MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ

Inclusion Criteria

Exclusion Criteria

Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)

Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer

Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)

The PREDICT Registry:

The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing

LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer