RecruitingInterventional

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

NCT ID: NCT05218044Sponsor: Glendale Adventist Medical Center d/b/a Adventist Health GlendaleLast updated: 2023-03-03

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.

Arms & interventions

ProcedureCryoablation
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 After the second freeze, the cryoprobe will be withdrawn from the breast and a bandage will be applied to the skin.

Outcome measures

Primary

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.
Time frame: 6 months

Secondary

Recurrence rate
Time frame: 5 years

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No

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 locations (1)

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

Glendale, California, 91206

Recruiting

Dennis Holmes, M.D. · Contact

800-203-5515

Dennis Holmes, M.D. · Principal Investigator