Clinical trial · Interventional
Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cryoablation
- 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.
- interventionNames
- Procedure: Cryoablation
Primary outcomes (1)
- measure
- Ability of cryoablation to achieve complete ablation of DCIS
- timeFrame
- 6 months
- 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.
Secondary outcomes (1)
- measure
- Recurrence rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available