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Cryoablation for Invasive Breast Carcinoma Following Neoadjuvant Therapy

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ClinicalTrials.gov Identifier: NCT01388777
Recruitment Status : Completed
First Posted : July 7, 2011
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Device: Visica 2™ Treatment System Procedure: Cryoablation Procedure: Surgical Resection Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Determine the Efficacy of Cryoablation for the Treatment of Invasive Breast Carcinoma Following Neoadjuvant Therapy
Actual Study Start Date : January 24, 2012
Primary Completion Date : June 14, 2017
Study Completion Date : June 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cryoablation
Cryoablation therapy followed by re-imaging then complete surgical resection.
Device: Visica 2™ Treatment System
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.
Procedure: Cryoablation
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.
Procedure: Surgical Resection
Complete surgical resection of the primary tumor following cryoablation therapy.
Other Name: Surgery



Primary Outcome Measures :
  1. Rate of Complete Ablation [ Time Frame: 2-4 weeks after cryoablation ]
    Complete ablation is defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion. The rate computed as the number of patients with complete tumor ablation divided by the total number of eligible patients.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388777


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Rosa Hwang, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01388777     History of Changes
Other Study ID Numbers: 2010-0986
NCI-2011-01278 ( Registry Identifier: NCI CTRP )
First Posted: July 7, 2011    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Breast Carcinoma
Cryoablation
The Visica 2™ Treatment System
Unifocal primary invasive ductal breast carcinoma
Cryoprobe

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases