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

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

Status: Enrolling

Conditions: Ductal Carcinoma in Situ

Treatments: Procedure: Cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05218044

DCIS Cryo

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Cryoablation

Other group

Description:

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.

Treatment:

Procedure: Cryoablation