Nearly every invasive breast cancer begins its life as ductal carcinoma in situ (DCIS), which is commonly called pre-invasive breast cancer or non-invasive breast cancer. If not for the risk of invasive cancer and its potential to metastasize, surgical removal of DCIS would be completely unnecessary. Cryoablation or tumor freezing is a minimally invasive office procedure that has the potential to replace surgery as an invasive cancer prevention option for women with small areas of DCIS. In this study, cryoablation will provide a minimally-invasive invasive breast cancer treatment option for women with DCIS measuring 2 cm or less based on standard breast imaging (Ultrasound, Mammogram, +/- breast MRI).
In this study, eligible women will undergo cryoablation of DCIS instead of surgery. Six months after cryoalbation, all participants will undergo a repeat needle biopsy of the original site of DCIS to confirm complete killing of the DCIS. In addition, prior to cryoablation, most women will require insertion of an ultrasound-visible biopsy site marker to make it easier to accurately target the site of DCIS at the time of cryoablation. The need for radiation and/or anti-cancer medications will be determined by your personal oncologist. All study participants are expected to continue annual mammograms.
This study will enroll up to 30 patients. Patients will not be charged for the cryoablation procedure if their insurer does not pay for cryoablation procedure. All other standard breast procedures will be billed to your insurer. Usual insurance deductibles may apply.
1. Women Age 18 and older.
2. DCIS spanning 2 cm or less based on its radiographic appearance by mammography and/or breast contrast-enhanced MRI.
3. Diagnosis of DCIS by needle biopsy
4. No prior history of DCIS or invasive breast cancer in the same breast
5. No history of surgical biopsy and/or lumpectomy for diagnosis/treatment in the same breast
6. Adequate breast volume and skin clearance to permit cryoablation as assessed by Dr. Holmes. This excludes male and females with breasts too small to allow safe cryoablation
7. Non-pregnant, non-lactating, and no history of pregnancy within the preceding 6 months
8. No history of breast radiation in the same breast
What's involved in the study?
1. To be evaluated for the study, you must have an initial consultation with Dr. Holmes.
2. The initial consultation and follow-up visits may be performed via Telehealth.
3. Cryoablation must be performed by Dr. Holmes
4. Radiology procedures may be performed by the your local radiologist.
Key Steps in the Trial and Cost:
1. Consultation with Dr. Holmes ***
2. Official Review of needle biopsy pathology to confirm Diagnosis of DCIS **
3. Placement of ultrasound visit marker at site of DCIS by radiologist ***
3. Cryoablation performed by Dr. Holmes*
4. Needle biopsy of cryoablation site performed by radiologist 6 months after cryoablation ***
5. Review of needle biopsy pathology results ***
6. Follow-up mammogram yearly ***
7. Follow-up medication and radiation to be individualized and determined by treating physician(s)***
*Billed to Insurer, but NOT billed to patient if not paid by insurer
**Paid by Study Sponsor
***Billed To Insurer
Partially funded by Doterra, which provided a 1:1 match of donations made by women.
Partially Supported by California Oncology Research Institute (CORI), providing grant funding for IRB and pathology expenses.
Partially Supported by Dr. Holmes who will donate Professional Services, personnel and overhead expenses.
Partially Supported by IceCure Medical, Inc., which provided cryoablation equipment at reduced cost.
Research Coordinator and Assistant
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Founded in 2017