Subzero and Scorpion Trial

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


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.

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


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.)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note