Status:
RECRUITING
Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
Lead Sponsor:
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Collaborating Sponsors:
Helen Rey Breast Cancer Research Foundation
California Oncology Research Institute
Conditions:
Ductal Carcinoma in Situ
Eligibility:
FEMALE
18+ years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05218044
Start Date
November 1 2021
End Date
November 1 2026
Last Update
March 3 2023
Active Locations (1)
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1
Office of Dennis R. Holmes, M.D., F.A.C.S.
Glendale, California, United States, 91206