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

Glendale Adventist Medical Center d/b/a Adventist Health Glendale30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ductal Carcinoma in Situ

Interventions

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 After the second freeze, the cryoprobe will be withdrawn from the breast and a bandage will be applied to the skin.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Recurrence rate

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

Time frame: 5 years