Cryoablation of Small Breast Tumors in Early Stage Breast Cancer
NCT ID: NCT01992250
Last Updated: 2018-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2013-11-30
2023-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low Risk - Age 70+
Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
Visica 2 Treatment System
Cryoablation
Moderate Risk - Age 50-69
Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
Visica 2 Treatment System
Cryoablation
Interventions
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Visica 2 Treatment System
Cryoablation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
FEMALE
No
Sponsors
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Sanarus Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis R. Holmes, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
90210 Surgery Medical Center
Locations
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Arizona Breastnet
Scottsdale, Arizona, United States
90210 Surgery Medical Center
Beverly Hills, California, United States
City of Hope
Duarte, California, United States
Epic Care
Emeryville, California, United States
Diagnostic Center for Women, LLC
Miami, Florida, United States
Naples Community Hospital
Naples, Florida, United States
Ascension Crittenton Hospital
Rochester, Michigan, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Knoxville Comprehensive Breast Center
Knoxville, Tennessee, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Ogden Regional Hospital
Ogden, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Luci Tumyan, MD
Role: backup
Michael J Plaza, M.D.
Role: primary
Cristina Upegui
Role: backup
Elene Turzo, MSN, CRNP
Role: backup
Other Identifiers
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CP-00-0011
Identifier Type: -
Identifier Source: org_study_id
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