Clinical trial · Interventional
Cryoablation for Invasive Breast Carcinoma Following Neoadjuvant Therapy
A Pilot Study to Determine the Efficacy of Cryoablation for the Treatment of Invasive Breast Carcinoma Following Neoadjuvant Therapy
NCT01388777CI-TRIAL-00033788terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early termination leading to small number of subjects analyzed
Summary
Brief summary (as posted)
Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. The goal of this clinical research study is to learn about the level of effectiveness of using ultrasound-guided cryoablation in patients with invasive breast cancer. The safety of this procedure will also be studied.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation | Procedure | — | UNRESOLVED |
| Surgical Resection | Procedure | — | UNRESOLVED |
| Visica 2™ Treatment System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cryoablation
- description
- Cryoablation therapy followed by re-imaging then complete surgical resection.
- interventionNames
- Device: Visica 2™ Treatment System
- Procedure: Cryoablation
- Procedure: Surgical Resection
Primary outcomes (1)
- measure
- Rate of Complete Tumor Ablation
- timeFrame
- From cryoablation through 30 days from surgery
- description
- The rate of complete tumor ablation in the target lesion will be evaluated by pathologic review of the surgical specimen.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or ductal carcinoma in situ (DCIS) with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible. 2. Neoadjuvant chemotherapy or hormonal therapy for the index tumor is required. 3. Residual tumor size \</= 2.0 cm in greatest diameter. Specifically, the tumor must measure \</= 2.0 cm in the axis parallel to the treatment probe and \</= 1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by mammogram, ultrasound or MRI will be used to determine eligibility. 4. Tumor enhancement on pre-registration MRI. 5. Tumor with \<25% intraductal components in the aggregate. 6. Adequate breast size for safe cryoablation. Male breast cancer patients and female breast cancer 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. 7. Patients with prior in-situ or invasive breast carcinomas are eligible if the prior carcinomas occurred in the contralateral breast. Patients with prior in-situ or invasive carcinomas of the ipsilateral breast are not eligible. Exclusion Criteria: 1. History of open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. Note: Prior rotational and/or vacuum-assisted core biopsies are permitted if no significant distortion is seen on imaging that could obscure visualization and detection of residual disease on MRI, or visualization of cancer on ultrasound for cryoablation procedure. 2. Pregnant and/or lactating. 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. 3. Patient has contra-indication to an MRI examination, such as clips/prostheses/implants that are not MRI compatible, or compromised renal function, with a measured or calculated glomerular filtration rate of 60ml/min/1.73m\^2 4. Patients less than 18 years of age will not be included in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.