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NCT Number: NCT05218044

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Glendale, California, 91206, United States

Location status: Recruiting

Location contact

Dennis Holmes, M.D.

CONTACT

800-203-5515

Dennis Holmes, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Ability of cryoablation to achieve complete ablation of DCIS

    Time frame: 6 months

    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.

Secondary outcomes

  1. Recurrence rate

    Time frame: 5 years

    Number of participants at the 5-year rate of invasive breast cancer recurrence after cryoablation of DCIS measuring </= 2cm.

Study contacts

Contact information is provided by the study sponsor or research team.

Dennis R Holmes, M.D.

CONTACT

[email protected]

800-203-5515

Sponsors and collaborators

Lead sponsor

Glendale Adventist Medical Center d/b/a Adventist Health Glendale

Other

Collaborators

  • California Oncology Research Institute
  • Doterra Healing Hands Foundation
  • Helen Rey Breast Cancer Research Foundation

Registry information

Acronym: DCIS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 1, 2022
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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