Subzero and Scorpion Trial

NCT ID: NCT05032079

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2023-09-01

Brief Summary

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.

Conditions

Ductal Carcinoma in Situ

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Group Type: EXPERIMENTAL

cryoablation

Intervention Type: PROCEDURE

single probe ultrasound guided cryoablation

Interventions

cryoablation

single probe ultrasound guided cryoablation

Intervention Type: PROCEDURE

Other Intervention Names

cryosurgery

Eligibility Criteria

Inclusion Criteria

1. Age >= 18

2. 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.

3. 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.

4. 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.

5. No prior or planned neoadjuvant chemotherapy for breast cancer.

6. 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

1. Multifocal of multicentric carcinoma.

2. Pre-registration core biopsy with diagnosis of frank invasive carcinoma (not microinvasion) or lobular carcinoma.

3. Prior or planned neoadjuvant chemotherapy for breast cancer.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Larkin Community Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Plaza, MD

Role: PRINCIPAL_INVESTIGATOR

Diagnostic Center for Women

Ahkeel Allen, MD

Role: PRINCIPAL_INVESTIGATOR

Breast Care Center Miami

Locations

Breast Care Center Miami

Miami, Florida, United States

Diagnostic Center for Women

Miami, Florida, United States

Countries

United States

Other Identifiers

LCH-112020

Identifier Type: -

Identifier Source: org_study_id