Clinical trial NCT05032079: Subzero and Scorpion Trial
Official title: Pilot Study for the Cryoablation of Ductal Carcinoma In Situ: Subzero and Scorpion Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ductal Carcinoma in Situ
Lead sponsor: Larkin Community Hospital
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: complete tumor ablation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Breast Care Center Miami
state: Florida
city: Miami
country: United States
facility: Diagnostic Center for Women
state: Florida
Study officials:
affiliation: Diagnostic Center for Women
name: Michael J Plaza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Breast Care Center Miami
name: Ahkeel Allen, MD
role: PRINCIPAL_INVESTIGATOR
References: