Clinical trial · Interventional
Cryotherapy for Breast Cancer Trial
Evaluation of Safety and Feasibility of ICE-SENSE3TM , a Cryotherapy Device for Office-based Ultrasound- Guided Treatment of Breast Cancer
NCT01671943CI-TRIAL-00016802ICE-BREACCERcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the clinical feasibility and safety of the ICESENSE3TM cryotherapy system for the ablation of small malignant invasive breast tumors.
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 |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ice-Sense3TM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast carcinoma up to 2.0 cm
- interventionNames
- Device: Ice-Sense3TM
Primary outcomes (1)
- measure
- The rate of complete tumor ablation in patients treated with cryoablation, with complete tumor ablation defined as no remaining invasive or in-situ carcinoma present upon pathological examination of the surgical resection specimen
- timeFrame
- One month
Secondary outcomes (2)
- measure
- Adverse events
- timeFrame
- One month
- description
- To describe the adverse events associated with cryoablation in these patients.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. Patients with contralateral disease will remain eligible. Note: Results of ER, PR, HER-2/neu must be obtained on pre-registration needle core biopsy material. * Tumor size ≤ 2.0 cm in greatest diameter as measured by breast ultrasound, MRI and mammogram. The largest dimension measured will be used to determine eligibility. * Tumor enhancement on MRI * Tumor with \<25% intraductal components in the aggregate. * Non-pregnant and non-lactating patients. Patients of childbearing potential must have a negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be amenorrheic for \> 12 months to be considered not of childbearing potential. * Adequate breast size for safe cryoablation. Patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation. NOTE: The minimal distance of tumor margins from the breast skin should be analogous to the surgical margins of a lumpectomy. Exclusion Criteria: * Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive DCIS. * History of rotational vacuum assisted core biopsies, en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. * Prior or planned neoadjuvant chemotherapy for breast cancer. * Patients with thrombocytopenia and or any other coagulation abnormality
References
Publications (0)
Data not yet available
No reference posted for this study.