Subzero and Scorpion Trial

Ductal Carcinoma in Situ Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05032079
• Other study ID #: LCH-112020
• Status: Withdrawn
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2023
• Source: Larkin Community Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

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.

4. Retroglandular breast implants. (Please note that patients with retropectoral implants are allowed to enroll if they meet all other inclusion criteria.)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ

Intervention

Procedure:
• cryoablation
single probe ultrasound guided cryoablation

Locations

Country	Name	City	State
United States	Breast Care Center Miami	Miami	Florida
United States	Diagnostic Center for Women	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Larkin Community Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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