NCT05218044 Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
| NCT ID | NCT05218044 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Glendale Adventist Medical Center d/b/a Adventist Health Glendale |
| Condition | Ductal Carcinoma in Situ |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2021-11-01 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05218044 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ductal Carcinoma in Situ. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05218044 currently recruiting?
Yes, NCT05218044 is actively recruiting participants. Contact the research team at drholmesmd50@gmail.com for enrollment information.
Where is the NCT05218044 trial being conducted?
This trial is being conducted at Glendale, United States.
Who is sponsoring the NCT05218044 clinical trial?
NCT05218044 is sponsored by Glendale Adventist Medical Center d/b/a Adventist Health Glendale. The trial plans to enroll 30 participants.