Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Office of Dennis R. Holmes, M.D., F.A.C.S.
RECRUITING
Glendale
Contact Information
Primary
Dennis R Holmes, M.D.
drholmesmd50@gmail.com
800-203-5515
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 30
Treatments
Other: Cryoablation
Phase I, single-arm study to evaluate the ability of cryoablation to achieve complete ablation of DCIS in the cryoablation zone of necrosis as a potential alternative to surgery.
Related Therapeutic Areas
Sponsors
Collaborators: Helen Rey Breast Cancer Research Foundation, Doterra Healing Hands Foundation, California Oncology Research Institute
Leads: Glendale Adventist Medical Center d/b/a Adventist Health Glendale

This content was sourced from clinicaltrials.gov