Cryoablation for Invasive Breast Carcinoma Following Neoadjuvant Therapy
Condition: Breast Cancer
MeSH terms: Carcinoma; Breast Neoplasms
Intervention: Visica 2™ Treatment System; Cryoablation; Surgical Resection
Intervention description: The Visica 2™ Treatment System uses a closed system to circulate liquid nitrogen within the probe tip creating sub-freezing temperatures that result in precision cryoablation of the intended target tissue.; Cryoablation procedure uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. The cryoprobe needle insertion is done using ultrasound guide to reach target, procedure lasts about 20 minutes.; Complete surgical resection of the primary tumor following cryoablation therapy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: To determine 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 targeted lesion.
Masking: None (Open Label)
Enrollment: 1.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Breast Carcinoma; Cryoablation; The Visica 2™ Treatment System; Unifocal primary invasive ductal breast carcinoma; Cryoprobe

Summary:

      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.
    

Eligibility criteria:

        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.