## Protocol Section
### Identification Module
**NCT ID:** NCT05032079

**Brief Title:** Subzero and Scorpion Trial

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

#### Organization Study ID Info
**ID:** LCH-112020
#### Organization
**Class:** OTHER
**Full Name:** Larkin Community Hospital
### Status Module
#### Completion Date
**Date:** 2023-09-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-16

**Type:** ACTUAL

**Last Update Submit Date:** 2023-10-12

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2023-09-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-11-16

**Type:** ACTUAL

**Status Verified Date:** 2023-10

#### Study First Post Date
**Date:** 2021-09-02
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-27
**Study First Submit QC Date:** 2021-08-27
**Why Stopped:** Study Period Ended / Not Completed
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Larkin Community Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Ductal Carcinoma in Situ

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: cryoablation

**Label:** Treatment Arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment Arm

**Description:** single probe ultrasound guided cryoablation

**Name:** cryoablation

**Other Names:**

- cryosurgery

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** rate of complete tumor ablation defined as no remaining invasive or in situ carcinoma present upon pathological examination of excised tissue

**Measure:** complete tumor ablation

**Time Frame:** 2 years

### Eligibility Module

**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.)

**Gender Based:** True

**Maximum Age:** 95 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Miami

**Country:** United States

**Facility:** Breast Care Center Miami

**State:** Florida

**Zip:** 33173

**Location 2:**

**City:** Miami

**Country:** United States

**Facility:** Diagnostic Center for Women

**State:** Florida

**Zip:** 33173

#### Overall Officials

**Official 1:**

**Affiliation:** Diagnostic Center for Women

**Name:** Michael J Plaza, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Breast Care Center Miami

**Name:** Ahkeel Allen, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000018299

- Term: Neoplasms, Ductal, Lobular, and Medullary

- ID: D000071960

- Term: Breast Carcinoma In Situ

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M25356

- Name: Carcinoma, Ductal

- Relevance: HIGH

- As Found: Ductal Carcinoma

- ID: M5535

- Name: Carcinoma in Situ

- Relevance: HIGH

- As Found: Carcinoma in Situ

- ID: M5542

- Name: Carcinoma, Intraductal, Noninfiltrating

- Relevance: HIGH

- As Found: Ductal Carcinoma in Situ

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M895

- Name: Breast Carcinoma In Situ

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000002278

- Term: Carcinoma in Situ

- ID: D000044584

- Term: Carcinoma, Ductal

- ID: D000002285

- Term: Carcinoma, Intraductal, Noninfiltrating

### Misc Info Module

- Version Holder: 2024-05-24
