Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
NCT ID: NCT05218044
Last Updated: 2023-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2021-11-01
2026-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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 After the second freeze, the cryoprobe will be withdrawn from the breast and a bandage will be applied to the skin.
Interventions
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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 After the second freeze, the cryoprobe will be withdrawn from the breast and a bandage will be applied to the skin.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Helen Rey Breast Cancer Research Foundation
UNKNOWN
California Oncology Research Institute
UNKNOWN
Doterra Healing Hands Foundation
UNKNOWN
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
OTHER
Responsible Party
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Dennis Holmes
Principal Investigator
Locations
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Office of Dennis R. Holmes, M.D., F.A.C.S.
Glendale, California, United States
Countries
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Central Contacts
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Facility Contacts
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Dennis Holmes, M.D.
Role: primary
Other Identifiers
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DCIS Cryo
Identifier Type: -
Identifier Source: org_study_id
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