Subzero and Scorpion Trial

NCT05032079 | Withdrawn

• 1 other identifier: LCH-112020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Procedure: cryoablation

Interventions

cryoablation PROCEDURE

single probe ultrasound guided cryoablation

Also known as: cryosurgery

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 95 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Larkin Community Hospital: lead

Study Sites (2)

Breast Care Center Miami

Miami, Florida, 33173, United States

Location

Diagnostic Center for Women

Miami, Florida, 33173, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Michael J Plaza, MD

  Diagnostic Center for Women

  PRINCIPAL INVESTIGATOR

• Ahkeel Allen, MD

  Breast Care Center Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: November 16, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

US (2)