Recruiting

Cryoablation

Sponsor:

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

Code:

NCT05218044

Conditions

Ductal Carcinoma in Situ

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cryoablation

Study Details

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

Study ID

NCT05218044

Start date

Nov 1, 2021

Status verified date

Mar, 2023

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Cryoablation

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.

Interventions

Cryoablation

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 outcome measure

  • Ability of cryoablation to achieve complete ablation of DCIS [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Dennis R Holmes, M.D.

800-203-5515drholmesmd50@gmail.com

Locations

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

Recruiting

Glendale, California, United States, 91206

Contacts

Dennis Holmes, M.D.

800-203-5515

Principal Investigator:

Dennis Holmes, M.D.

More Information

Sponsor

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

Last update posted

Mar 3, 2023

Last verified

Mar, 2023

Keywords

  • DCIS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Glendale Adventist Medical Center d/b/a Adventist Health Glendale on 2023-03-03.