Subzero and Scorpion Trial

Study Overview
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Brief Summary
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This is a prospective single-institution pilot study examining the feasibility of performing ultrasound-guided cryoablation to completely ablate breast ductal carcinoma in situ (DCIS). The study is designed such that patients meeting selection criteria will undergo cryoablation followed by surgical resection. The pathology of the surgical specimen will be used to determine the rate of complete tumor ablation. Standard adjuvant therapies otherwise remained unchanged.

Official Title
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Pilot Study for the Cryoablation of Ductal Carcinoma In Situ: Subzero and Scorpion Trial

Conditions
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Ductal Carcinoma in Situ

Intervention / Treatment
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* Procedure: cryoablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 Pre-registration core biopsy: Unifocal primary ductal carcinoma in situ (DCIS) or atypical ductal hyperplasia (ADH) bordering on DCIS or DCIS with microinvasion diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer are NOT eligible. Patients with contralateral disease will remain eligible. Tumor size < 1.5 cm in greatest diameter. Specifically, the tumor must measure < 1.5 cm in the axis parallel to the treatment probe and < 1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by required pre-treatment scans (mammogram, ultrasound and MRI) will be used to determine eligibility. An ultrasound visible target for cryoablation: Ultrasound-visible mass or nonmass finding corresponding to the tumor or An ultrasound-visible biopsy marker placed within 1cm of the biopsied tumor. No prior or planned neoadjuvant chemotherapy for breast cancer. Adequate breast size for safe cryoablation. This will be determined by the interventional radiologist using a combination of clinical exam and imaging. Site of target for cryoablation must be greater than 1 cm from the nipple and greater than 1cm from the closest skin surface. Exclusion Criteria: Multifocal of multicentric carcinoma. Pre-registration core biopsy with diagnosis of frank invasive carcinoma (not microinvasion) or lobular carcinoma. Prior or planned neoadjuvant chemotherapy for breast cancer. Retroglandular breast implants. (Please note that patients with retropectoral implants are allowed to enroll if they meet all other inclusion criteria.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br> | Procedure: cryoablation<br>* single probe ultrasound guided cryoablation<br>* Other names: cryosurgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete tumor ablation | rate of complete tumor ablation defined as no remaining invasive or in situ carcinoma present upon pathological examination of excised tissue | 2 years |