Actively Recruiting
Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
Led by Glendale Adventist Medical Center d/b/a Adventist Health Glendale · Updated on 2023-03-03
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Lead Sponsor
H
Helen Rey Breast Cancer Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cryoablation, or tumor freezing, is being studied as a minimally invasive and cost-effective alternative to surgery for managing early-stage invasive breast cancer, specifically for small areas of ductal carcinoma in situ (DCIS). This research aims to evaluate whether cryoablation can successfully destroy DCIS within the targeted area. The study is a Phase I, single-arm trial sponsored by Glendale Adventist Medical Center to explore this potential new treatment option. Participants will undergo cryoablation where a cryoprobe is inserted into the breast under ultrasound guidance to the area marked for treatment. The probe freezes a 4 x 3 x 3 cm area of DCIS through two 10-minute freeze cycles separated by a 10-minute thaw cycle, while remaining in place. After the procedure, the probe is removed and a bandage is applied. This procedure is performed in an office setting as a less invasive option compared to surgery. Participants will be monitored to assess if cryoablation achieves complete ablation of DCIS after 6 months. Additional tracking includes the recurrence rate of DCIS over five years. The study involves imaging evaluations and clinical assessments to measure treatment success and safety. Total involvement duration includes follow-up visits to observe long-term outcomes after the procedure.
CONDITIONS
Brief Title
Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Non-pregnant, non-lactating, and no history of pregnancy within the preceding 6 months
- No history of breast radiation in the same breast
You will not qualify if you...
- Male or females with breasts too small to allow safe cryoablation
- Pregnant or lactating women
- History of pregnancy within the last 6 months
- History of breast radiation in the same breast
- Prior breast surgery, biopsy, or lumpectomy on the same breast
- Prior history of DCIS or invasive breast cancer in the same breast
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo cryoablation where a cryoprobe is inserted into the breast to freeze the area of DCIS using two 10-minute freeze cycles separated by a 10-minute thaw cycle.
1 procedure visit (in-person)
Duration - Up to 5 years
Participants are monitored to assess the ability of cryoablation to achieve complete ablation of DCIS and to track recurrence rates.
Periodic visits over 5 years
Trial Site Locations
Total: 1 location
1
Office of Dennis R. Holmes, M.D., F.A.C.S.
Glendale, California, United States, 91206
Actively Recruiting
Research Team
D
Dennis R Holmes, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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