We are one of the official trial locations for ICE3 trials. Please contact us at 214-501-5427 if you are interested in participating in this trial.
What is ICE3
We are currently enrolling patients in the landmark, multi-center ICE3 trial, where certain breast cancers will be cryoablated, then followed. No Surgery. We also support investigator-initiated studies at various academic institutions around the globe, including Kameda and St. Johns.
Because it utilizes the more advanced IceSense3 cryoablation system with low, stable, cryo temperatures, ICE3 has the potential to completely ablate tumors up to 1.5 cm.
Why is the IceSense3™ procedure the best option?
The IceSense3™ cryoablation procedure is a safe and effective way to treat breast fibroadenomas. A simple, ultrasound-guided office-based procedure can address the anxiety of living with an uncomfortable tumor in your breast. Further, the size and shape of your breast will not be affected as the treated tissue is gradually reabsorbed.
Our clinical trial will recruit and follow-up on women aged 65 years or older diagnosed with luminal A breast carcinoma whose tumors measure less than 1.5 centimeters in diameter. These patients will also receive adjunctive therapy based on local standards of care.
The trial was crafted by a diverse and esteemed scientific advisory board will be conducted at 20 carefully selected sites throughout the United States and utilize IceSense3 consoles already installed for the treatment of fibroadenomas. As a market leader in cryoablation treatment of fibroadenomas, we will utilize our resources to provide clinical and technological support to sites.
The benefits of utilizing cryoablation to treat breast disease versus the historical treatment of excision or mastectomy are numerous. Cryoablation can be performed in a physician’s office with use of local anesthetic and ultrasound. Additionally, because no tissue is removed, there is minimal cosmetic impact with little to no scarring or permanent disfigurement. Further, cryoablation is an economically sound alternative to costly surgery.
Simmons, R. Abstract Title: A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma: Results from ACOSOG (Alliance) Z1072.
Sabel MS, Su G, Griffith KA et al. Rate of Freeze Alters the Immunologic Response After Cryoablation of Breast Cancer. Annals of Surgical Oncology; Vol.17 Issue 4, Apr. 2009.
The procedure takes place in a physician’s office. Your doctor will use ultrasound (sonographic) imaging to guide a small probe (thin hollow needle) into the fibroadenoma, after local anesthesia. Extremely cold temperatures are used to destroy (ablate) the fibroadenoma. The procedure is comfortable and painless, as the cold acts with the local anesthesia to numb the area.
The procedure usually takes about 10-15 minutes. No sutures are required; as the procedure is performed using only a small skin nick, just an adhesive steri-strip is needed. As with a needle biopsy, many women can return to work or their normal activity quickly.