A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma
- To determine the rate of complete tumor ablation in patients with invasive ductal
breast carcinoma treated with cryoablation.
- To evaluate the negative predictive value of MRI in the post-ablation setting in
detecting residual in situ or invasive breast carcinoma.
- To describe the adverse events associated with cryoablation in these patients.
- To prospectively gather pain assessment data before and after cryoablation and after
surgical resection in these patients.
- To explore technical variables that may affect the success of cryoablation in these
OUTLINE: This is a multicenter study.
A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion.
Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or
8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node
biopsy and/or axillary dissection within 28 days after completion of cryoablation.
Patients complete the Brief Pain Inventory before and after cryoablation and after surgery.
After completion of study treatment, patients are followed within 14 days.
Allocation: Non-Randomized, Primary Purpose: Treatment
Rate of complete tumor ablation
Rache M. Simmons, MD
Weill Medical College of Cornell University
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Bridgeport Hospital||Bridgeport, Connecticut 06610|
|Northwest Community Hospital||Arlington Heights, Illinois 60005|
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Lankenau Cancer Center at Lankenau Hospital||Wynnewood, Pennsylvania 19096|
|DeCesaris Cancer Institute at Anne Arundel Medical Center||Annapolis, Maryland 21401|
|Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|Bethesda North Hospital||Cincinnati, Ohio 45242|
|Bellingham Breast Center||Bellingham, Washington 98225|