Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ (DCIS)
Primary Purpose
Ductal Carcinoma in Situ
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryoablation
Sponsored by
About this trial
This is an interventional treatment trial for Ductal Carcinoma in Situ focused on measuring DCIS
Eligibility Criteria
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
Sites / Locations
- Office of Dennis R. Holmes, M.D., F.A.C.S.Recruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cryoablation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Recurrence rate
Number of participants at the 5-year rate of invasive breast cancer recurrence after cryoablation of DCIS measuring </= 2cm.
Full Information
NCT ID
NCT05218044
First Posted
December 23, 2021
Last Updated
March 2, 2023
Sponsor
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Collaborators
Helen Rey Breast Cancer Research Foundation, California Oncology Research Institute, Doterra Healing Hands Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05218044
Brief Title
Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
Acronym
DCIS
Official Title
Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Collaborators
Helen Rey Breast Cancer Research Foundation, California Oncology Research Institute, Doterra Healing Hands Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Carcinoma in Situ
Keywords
DCIS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cryoablation
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cryoablation
Intervention Description
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 Information:
Title
Ability of cryoablation to achieve complete ablation of DCIS
Description
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 Outcome Measure Information:
Title
Recurrence rate
Description
Number of participants at the 5-year rate of invasive breast cancer recurrence after cryoablation of DCIS measuring </= 2cm.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis R Holmes, M.D.
Phone
800-203-5515
Email
drholmesmd50@gmail.com
Facility Information:
Facility Name
Office of Dennis R. Holmes, M.D., F.A.C.S.
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Holmes, M.D.
Phone
800-203-5515
First Name & Middle Initial & Last Name & Degree
Dennis Holmes, M.D.
12. IPD Sharing Statement
Learn more about this trial
Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
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