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

Not Applicable

Recruiting

• Conditions: Ductal Carcinoma in Situ
• Interventions: Procedure: Cryoablation

• Registration Number: NCT05218044
• Lead Sponsor: Glendale Adventist Medical Center d/b/a Adventist Health Glendale

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-12-23
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryoablation	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.

Primary Outcome Measures

Name	Time	Method
Ability of cryoablation to achieve complete ablation of DCIS	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 Outcome Measures

Name	Time	Method
Recurrence rate	5 years	Number of participants at the 5-year rate of invasive breast cancer recurrence after cryoablation of DCIS measuring \</= 2cm.

Trial Locations

Locations (1)

Office of Dennis R. Holmes, M.D., F.A.C.S.; 🇺🇸 Glendale, California, United States