Spots Global Cancer Trial Database for Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer
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Trial Identification
Brief Title: Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer
Official Title: A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma
Study ID: NCT00723294
Conditions
Study Description
Brief Summary: This phase II trial is studying how well cryoablation therapy works in treating patients with invasive ductal breast cancer. Cryoablation kills tumor cells by freezing them. This may be an effective treatment for patients with invasive ductal breast cancer.
Detailed Description: This is a phase II non-randomized exploratory study. All fully eligible and registered patients will undergo imaging by mammography, ultrasound, and breast MRI. Patients will then undergo complete surgical resection of the primary tumor. The primary and secondary objectives of the study are described below. OBJECTIVES: Primary * To determine the rate of complete tumor ablation in patients treated with cryoablation, with complete tumor ablation defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion Secondary * To evaluate the negative predictive value of MRI in the post-ablation setting to determine residual in situ or invasive breast carcinoma * To describe the adverse events associated with cryoablation * To prospectively gather pain assessment data on cryoablation and surgical resection * Explore technical variables that may affect the success of cryoablation
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Providence Saint Joseph Medical Center, Burbank, California, United States
Bridgeport Hospital, Bridgeport, Connecticut, United States
University of South Florida College of Medicine, Tampa, Florida, United States
Northwest Community Hospital, Arlington Heights, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Indiana University Hospital/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center, Annapolis, Maryland, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States
New York Weill Cornell Cancer Center at Cornell University, New York, New York, United States
Bethesda North Hospital, Cincinnati, Ohio, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Bellingham Breast Center, Bellingham, Washington, United States
Contact Details
Name: Rache M. Simmons, MD
Affiliation: Weill Medical College of Cornell University
Role: STUDY_CHAIR
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