Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ

NCT05218044 | Recruiting

• 1 other identifier: DCIS Cryo
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. The investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of DCIS by examining its ability to achieve complete ablation of DCIS within the targeted cryoablation zone of necrosis.

Conditions

Ductal Carcinoma in Situ

Keywords

DCIS

Outcome Measures

Primary Outcomes (1)

• Ability of cryoablation to achieve complete ablation of DCIS

  Number of participants to achieve completeness of ablation by measuring the percentage of subjects with no residual DCIS or invasive cancer within the zero of necrosis assessed in the post-cryoablation core biopsy obtained 6 months post-cryoablation.

  6 months

Secondary Outcomes (1)

• Recurrence rate

  5 years

Study Arms (1)

Cryoablation

OTHER

Phase I, single-arm study to evaluate the ability of cryoablation to achieve complete ablation of DCIS in the cryoablation zone of necrosis as a potential alternative to surgery.

Procedure: Cryoablation

Interventions

Cryoablation PROCEDURE

The cryoprobe tip will be inserted into the breast and directed under ultrasound guidance to the location where the ultrasound visible marker is located. Next, the cryoprobe will be used to freeze a 4 X 3 X 3 cm diameter area of DCIS using two separate 10-minute freeze cycles separated by a single 10-minute thaw cycle. The cryoprobe will remain in place the entire time. After the second freeze, the cryoprobe will be withdrawn from the breast and a bandage will be applied to the skin.

Cryoablation

Eligibility Criteria

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

You may qualify if:

• DCIS spanning 2 cm or less based on its radiographic appearance by mammography and/or breast contrast-enhanced MRI
• Diagnosis of DCIS by minimally invasive needle biopsy
• No prior history of DCIS or invasive breast cancer in the same breast
• No history of surgical biopsy and/or lumpectomy for diagnosis/treatment in the same breast
• Adequate breast volume and skin clearance to permit cryoablation as assessed by Dr. Holmes. This excludes male and females with breasts too small to allow safe cryoablation
• Non-pregnant, non-lactating, and no history of pregnancy within the preceding 6 months
• No history of breast radiation in the same breast

Sponsors & Collaborators

• Glendale Adventist Medical Center d/b/a Adventist Health Glendale: lead
• Helen Rey Breast Cancer Research Foundation: collaborator
• California Oncology Research Institute: collaborator
• Doterra Healing Hands Foundation: collaborator

Study Sites (1)

Office of Dennis R. Holmes, M.D., F.A.C.S.

Glendale, California, 91206, United States

RECRUITING

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

Central Study Contacts

Dennis R Holmes, M.D.

CONTACT

800-203-5515; drholmesmd50@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: February 1, 2022
• Study Start: November 1, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

US (1)