Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments visica 2™ treatment system, cryoablation, surgical resection
Phase phase 2
Sponsor M.D. Anderson Cancer Center
Start date January 2012
End date January 2018
Trial size 10 participants
Trial identifier NCT01388777, 2010-0986, NCI-2011-01278

Summary

Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue.

The goal of this clinical research study is to learn about the level of effectiveness of using ultrasound-guided cryoablation in patients with invasive breast cancer. The safety of this procedure will also be studied.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cryoablation therapy followed by re-imaging then complete surgical resection.
visica 2™ treatment system
The Visica 2™ Treatment System uses a closed system to circulate liquid nitrogen within the probe tip creating sub-freezing temperatures that result in precision cryoablation of the intended target tissue.
cryoablation
Cryoablation procedure uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. The cryoprobe needle insertion is done using ultrasound guide to reach target, procedure lasts about 20 minutes.
surgical resection Surgery
Complete surgical resection of the primary tumor following cryoablation therapy.

Primary Outcomes

Measure
Rate of Complete Ablation
time frame: 2-4 weeks after cryoablation

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or DCIS with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible. 2. Neoadjuvant chemotherapy or hormonal therapy for the index tumor is required. 3. Residual tumor size 12 months to be considered not of childbearing potential. 3. Patient has contra-indication to an MRI examination, such as clips/prostheses/implants that are not MRI compatible, or compromised renal function, with a measured or calculated glomerular filtration rate of 60ml/min/1.73m^2 4. Patients less than 18 years of age will not be included in this study.

Additional Information

Official title A Pilot Study to Determine the Efficacy of Cryoablation for the Treatment of Invasive Breast Carcinoma Following Neoadjuvant Therapy
Principal investigator Rosa Hwang, MD
Description Study Procedure: To perform cryoablation in this study, the doctor will insert the cryoprobe like a needle until the tip rests in about the middle of the cancerous area. In this study, an ultrasound imaging device will also be used to allow the doctor to see where to insert the cryoprobe. If you are found to be eligible and agree to take part in this study, you will have an ultrasound-guided biopsy to confirm your diagnosis. To perform an ultrasound-guided biopsy, a tissue sample will be withdrawn from your breast using a needle and a syringe. A very small amount of tissue will be taken. The needle is guided while being viewed by the doctor on an ultrasound. Cryoablation: Before you have the cryoablation procedure, blood (about 1 teaspoon) will be drawn for routine tests. Within 30 days after you join this study, the cryoablation procedure will be performed. The affected area will first be numbed with anesthetic. Your study doctor will insert the cryoprobe needle and use an ultrasound device to help guide the cryoprobe until it reaches the cancerous area. When in place, the cryoprobe will be used to freeze the cancerous area. The doctor will be very careful to try to avoid damaging the surrounding normal tissue. The cryoablation procedure will last about 20 minutes. The cryoprobe will be removed when your doctor thinks the cancerous area has been treated as much as possible. There will be a small wound, like a puncture wound from a large needle. Most likely, you will not need any stitches to close this wound. First Follow-Up Visit: About 2-4 weeks after cryoablation: - You will have a physical exam. - You will have an MRI scan of the breast to check the status of the disease. This scan is for research purposes only. Researchers want to learn if an MRI scan after cryoablation can detect any remaining breast cancer. Your MRI scans and the ultrasound images will be reviewed by the study radiologist. This will include the MRI scans from before and after cryoablation, and the ultrasound images from during cryoablation. Surgery: Within 4 weeks after cryoablation, you will have standard-of-care surgery to remove the remaining area that was treated during cryoablation. You will be asked to sign a separate consent form that describes the surgery in more detail. After surgery, the doctor will also check to see if the cryoablation destroyed all of the cancerous area. This will help researchers learn if cryoablation is effective. Second Follow-Up Visit: About 2 weeks after surgery: - You will have a physical exam. - You will be asked about any side effects you may have had from the cryoablation and surgery. When you have finished cryoablation and surgery, you and your doctor will decide if you need additional treatment. Additional treatment is not considered part of this study. Your doctor will be able to answer questions you may have about additional treatment. Length of Study Participation: You will remain on study for about 2 months. You will be taken off study early if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. This is an investigational study. The ultrasound-guided cryoablation system that will be used for your cryoablation procedure has been FDA-approved for use in cancer. The use of this system for breast cancer after chemotherapy is investigational. Up to 10 patients will take part in this study. All will be enrolled at MD Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.