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Trial record 1 of 1 for:    breast cancer cryoablation frost
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Cryoablation of Small Breast Tumors in Early Stage Breast Cancer (FROST)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Sanarus Technologies, Inc.
Sponsor:
Information provided by (Responsible Party):
Sanarus Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01992250
First received: November 6, 2013
Last updated: August 11, 2017
Last verified: May 2017
  Purpose
This study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer. The hypothesis is that cryoablation will complete ablation and destroy the tumor in a selected population of women who may otherwise be adequately treated with surgery.

Condition Intervention
Breast Cancer Device: Visica 2 Treatment System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Sanarus Technologies, Inc.:

Primary Outcome Measures:
  • Tumor ablation occurence [ Time Frame: Within 6 months ]
    Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma. Will be determined at 6-month post-cryoablation biopsy. Residual disease will require surgery.


Secondary Outcome Measures:
  • Local tumor recurrence [ Time Frame: Within 5 years ]
  • Satisfactory breast cosmesis results [ Time Frame: 5 Years ]
  • Adverse event assessment [ Time Frame: 5 years ]

Estimated Enrollment: 200
Study Start Date: November 2013
Estimated Study Completion Date: June 2023
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Low Risk - Age 70+
Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
Device: Visica 2 Treatment System
Cryoablation
Other Name: Visica Breast Therapy
Moderate Risk - Age 50-69
Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
Device: Visica 2 Treatment System
Cryoablation
Other Name: Visica Breast Therapy

Detailed Description:

PURPOSE:

To determine the rate of successful tumor ablation in patients treated with cryoablation and endocrine therapy in a subset of patients with early stage breast cancer.

OUTLINE:

  1. Core Biopsy (Pre-Registration)
  2. Magnetic Resonance Imaging (Pre-Registration)
  3. Tumor Cryoablation
  4. Core Biopsy (Post-Cryoablation)
  5. Magnetic Resonance Imaging (Post-Cryoablation)
  6. Postoperative Follow-up
  7. Evaluation of outcomes
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 50
  2. Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy
  3. Maximum tumor size ≤1.5 cm in its greatest diameter
  4. Ultrasound visible lesion(s)
  5. Clinically node negative, hormone receptor positive (+). HER2 negative (-), with <25% intraductal component in the aggregate.
  6. Unilateral or bilateral disease meeting study criteria
  7. Physical and emotional ability to undergo baseline and follow-up breast MRIs and serial breast cosmesis analysis
  8. Patient agrees to receive a 5 year minimum course of endocrine therapy following cryoablation for control of systemic disease

Exclusion Criteria:

  1. Prior treatment (e.g., open surgical biopsy, lumpectomy) of index cancer
  2. Ductal carcinoma in-situ with microinvasions (T1mic)
  3. Multifocal or multicentric invasive breast carcinoma
  4. Prior or planned neoadjuvant systemic therapy for breast cancer
  5. Tumor with ≥25% IDC components
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992250

Contacts
Contact: Pamela Ellis (925) 460-6080 clinical@sanarus.com

Locations
United States, Alabama
Cancer Surgery of Mobile Recruiting
Mobile, Alabama, United States, 36607
Contact: Sharla Patterson, M.D.    251-433-5557      
Contact: Monica Darby, R.N.    251-433-5557      
United States, California
90210 Surgery Medical Center Recruiting
Beverly Hills, California, United States, 90210
Contact: Gerald Coronado    310-651-2050    gerald@drholmesmd.com   
Principal Investigator: Dennis R. Holmes, MD, FACS         
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Blanca Mendez, BSHS CRCII    626-218-0433 ext 80433    blmendez@coh.org   
Contact: Luci Tumyan, MD    626-218-0433 ext 80433      
United States, Florida
Diagnostic Center for Women, LLC Recruiting
Miami, Florida, United States, 33173
Contact: Michael J Plaza, M.D.    305-740-5100      
Contact: Cristina Upegui    305-740-5100 ext 2004      
United States, Pennsylvania
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Sharon Steinberg, BS, RN, OCN    484-476-2395    SteinbergS@MLHS.ORG   
Contact: Diana Ewen, MPH, CCRP    484-476-2649    EwenD@MLHS.org   
Principal Investigator: Ned Z Carp, M.D.         
Sub-Investigator: Jennifer L Sabol, M.D.         
Sub-Investigator: Robin Ciocca, D.O.         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Liz Lorrell    401-444-2277    emorrell@lifespan.org   
Principal Investigator: Robert Ward, M.D>         
United States, Tennessee
Knoxville Comprehensive Breast Center Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Miranda Stinnett    865-583-1014    mstinnett@kcbc-center.com   
Principal Investigator: Kamilia Kozlowski, MD         
Principal Investigator: Caryn Wunderlich, MD         
Nashville Breast Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Kristie Appleton    615-620-5535 ext 4310    kristie@nashvillebreastcenter.com   
Principal Investigator: Pat Whitworth, M.D.         
United States, Texas
Texas Tech University Health Sciences Center Recruiting
Lubbock, Texas, United States, 79416
Contact: Melanie Bisbee    806-775-8597    Melanie.Bisbee@umchealthsystem.com   
Principal Investigator: Rakhshanda Rahman, MD         
Sponsors and Collaborators
Sanarus Technologies, Inc.
Investigators
Principal Investigator: Dennis R. Holmes, MD, FACS 90210 Surgery Medical Center
  More Information

Responsible Party: Sanarus Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01992250     History of Changes
Other Study ID Numbers: CP-00-0011
Study First Received: November 6, 2013
Last Updated: August 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sanarus Technologies, Inc.:
Cryoablation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2017