Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ductal Carcinoma in Situ
- Sponsor
- Glendale Adventist Medical Center d/b/a Adventist Health Glendale
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Ability of cryoablation to achieve complete ablation of DCIS
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Dennis Holmes
Principal Investigator
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Ability of cryoablation to achieve complete ablation of DCIS
Time Frame: 6 months
Number of participants to achieve completeness of ablation by measuring the percentage of subjects with no residual DCIS or invasive cancer within the zero of necrosis assessed in the post-cryoablation core biopsy obtained 6 months post-cryoablation.
Secondary Outcomes
- Recurrence rate(5 years)