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

Ductal Carcinoma in Situ Clinical Trial

— DCIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218044
• Other study ID #: DCIS Cryo
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 1, 2026

Study information

• Verified date: March 2023
• Source: Glendale Adventist Medical Center d/b/a Adventist Health Glendale
• Contact: Dennis R Holmes, M.D.
• Phone: 800-203-5515
• Email: drholmesmd50[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ

Intervention

Procedure:
• Cryoablation
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

Country	Name	City	State
United States	Office of Dennis R. Holmes, M.D., F.A.C.S.	Glendale	California

Sponsors (4)

Lead Sponsor	Collaborator
Glendale Adventist Medical Center d/b/a Adventist Health Glendale	California Oncology Research Institute, Doterra Healing Hands Foundation, Helen Rey Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of cryoablation to achieve complete ablation of DCIS	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.	6 months
Secondary	Recurrence rate	Number of participants at the 5-year rate of invasive breast cancer recurrence after cryoablation of DCIS measuring	5 years