Subzero and Scorpion Trial

Withdrawn before enrolling · Not applicable

Conditions studied: Ductal Carcinoma in Situ

In brief

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.

Key facts

Study ID

NCT05032079

Run by

Larkin Community Hospital

People needed

0

Starts

2020-11-16

Expected to finish

2023-09-01

Last updated by the study team

2023-10-16

Who can join

Age: 18 and older, up to 95. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.)

Where it is running

• Breast Care Center Miami — Miami, Florida, United States
• Diagnostic Center for Women — Miami, Florida, United States

Full record on ClinicalTrials.gov

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