Subzero and Scorpion Trial

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    20
  • sponsor
    Larkin Community Hospital
Updated on 11 September 2021
cancer
breast cancer
carcinoma in situ
lobular carcinoma
mammogram
core needle biopsy

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.

Details
Condition Ductal Carcinoma In Situ, dcis, Malignant Adenoma, Ductal Carcinoma In Situ (DCIS), Adenocarcinoma
Treatment Cryoablation
Clinical Study IdentifierNCT05032079
SponsorLarkin Community Hospital
Last Modified on11 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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.)
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