Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
30 participants
Nov 1, 2021
INTERVENTIONAL
Conditions
Summary
Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. The investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of DCIS by examining its ability to achieve complete ablation of DCIS within the targeted cryoablation zone of necrosis.
Eligibility
Inclusion Criteria7
- DCIS spanning 2 cm or less based on its radiographic appearance by mammography and/or breast contrast-enhanced MRI
- Diagnosis of DCIS by minimally invasive needle biopsy
- No prior history of DCIS or invasive breast cancer in the same breast
- No history of surgical biopsy and/or lumpectomy for diagnosis/treatment in the same breast
- 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
- Non-pregnant, non-lactating, and no history of pregnancy within the preceding 6 months
- No history of breast radiation in the same breast
Interventions
The cryoprobe tip will be inserted into the breast and directed under ultrasound guidance to the location where the ultrasound visible marker is located. Next, the cryoprobe will be used to freeze a 4 X 3 X 3 cm diameter area of DCIS using two separate 10-minute freeze cycles separated by a single 10-minute thaw cycle. The cryoprobe will remain in place the entire time. After the second freeze, the cryoprobe will be withdrawn from the breast and a bandage will be applied to the skin.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05218044