Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether freezing a tumor can fully destroy small areas of ductal carcinoma in situ (DCIS), cancer inside the breast’s milk ducts. It is for people with DCIS measuring 2 cm or less and looks at freezing as a possible option instead of surgery.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- DCIS measures 2 cm or less on a mammogram, a breast MRI with contrast dye, or both.
- DCIS was diagnosed using a needle biopsy, which removes a small tissue sample.
- No past DCIS or invasive breast cancer (cancer that has spread beyond the milk ducts) in the same breast.
- No past surgery to take a tissue sample or remove a lump in the same breast.
- Enough breast tissue and space between the tumor and skin for safe freezing, as judged by Dr. Holmes. Males and females with breasts too small for safe freezing cannot join.
- Not pregnant or breastfeeding, and no pregnancy in the past 6 months.
- No past radiation treatment in the same breast.
Who can't join
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
CA
- Office of Dennis R. Holmes, M.D., F.A.C.S. · Glendale, CA 91206Dennis Holmes, M.D. · Study contact · 800-203-5515Dennis Holmes, M.D. · Principal investigatorMore trials in Glendale