Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-04-18 @ 6:48 AM
Study NCT ID:
NCT01992250
Status:
UNKNOWN
Last Update Posted:
2018-04-20
First Post:
2013-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoablation of Small Breast Tumors in Early Stage Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2013-11-06', 'studyFirstSubmitQcDate': '2013-11-18', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor ablation occurence', 'timeFrame': 'Within 6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Local tumor recurrence', 'timeFrame': 'Within 5 years'}, {'measure': 'Satisfactory breast cosmesis results', 'timeFrame': '5 Years'}, {'measure': 'Adverse event assessment', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cryoablation'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PURPOSE:\n\nTo 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.\n\nOUTLINE:\n\n1. Core Biopsy (Pre-Registration)\n2. Magnetic Resonance Imaging (Pre-Registration)\n3. Tumor Cryoablation\n4. Core Biopsy (Post-Cryoablation)\n5. Magnetic Resonance Imaging (Post-Cryoablation)\n6. Postoperative Follow-up\n7. Evaluation of outcomes'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 50\n2. Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy\n3. Maximum tumor size ≤1.5 cm in its greatest diameter\n4. Ultrasound visible lesion(s)\n5. Clinically node negative, hormone receptor positive (+). HER2 negative (-), with \\<25% intraductal component in the aggregate.\n6. Unilateral or bilateral disease meeting study criteria\n7. Physical and emotional ability to undergo baseline and follow-up breast MRIs and serial breast cosmesis analysis\n8. Patient agrees to receive a 5 year minimum course of endocrine therapy following cryoablation for control of systemic disease\n\nExclusion Criteria:\n\n1. Prior treatment (e.g., open surgical biopsy, lumpectomy) of index cancer\n2. Ductal carcinoma in-situ with microinvasions (T1mic)\n3. Multifocal or multicentric invasive breast carcinoma\n4. Prior or planned neoadjuvant systemic therapy for breast cancer\n5. Tumor with ≥25% IDC components'}, 'identificationModule': {'nctId': 'NCT01992250', 'acronym': 'FROST', 'briefTitle': 'Cryoablation of Small Breast Tumors in Early Stage Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanarus Technologies, Inc.'}, 'officialTitle': 'Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer', 'orgStudyIdInfo': {'id': 'CP-00-0011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Low Risk - Age 70+', 'description': 'Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies', 'interventionNames': ['Device: Visica 2 Treatment System']}, {'type': 'OTHER', 'label': 'Moderate Risk - Age 50-69', 'description': 'Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies', 'interventionNames': ['Device: Visica 2 Treatment System']}], 'interventions': [{'name': 'Visica 2 Treatment System', 'type': 'DEVICE', 'otherNames': ['Visica Breast Therapy'], 'description': 'Cryoablation', 'armGroupLabels': ['Low Risk - Age 70+', 'Moderate Risk - Age 50-69']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tracey Peters', 'role': 'CONTACT', 'email': 'tracey@breastnet.net', 'phone': '480-314-7600'}, {'name': 'Belinda Barcley-White, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arizona Breastnet', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gerald Coronado', 'role': 'CONTACT', 'email': 'gerald@drholmesmd.com', 'phone': '310-651-2050'}, {'name': 'Dennis R. Holmes, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '90210 Surgery Medical Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Blanca Mendez, BSHS CRCII', 'role': 'CONTACT', 'email': 'blmendez@coh.org', 'phone': '626-218-0433', 'phoneExt': '80433'}, {'name': 'Luci Tumyan, MD', 'role': 'CONTACT', 'phone': '626-218-0433', 'phoneExt': '80433'}], 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '94608', 'city': 'Emeryville', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shoko Abe, M.D.', 'role': 'CONTACT', 'email': 'Shoko.Abe@epic-care.com', 'phone': '510-629-6682'}], 'facility': 'Epic Care', 'geoPoint': {'lat': 37.83132, 'lon': -122.28525}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael J Plaza, M.D.', 'role': 'CONTACT', 'phone': '305-740-5100'}, {'name': 'Cristina Upegui', 'role': 'CONTACT', 'phone': '305-740-5100', 'phoneExt': '2004'}], 'facility': 'Diagnostic Center for Women, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34109', 'city': 'Naples', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patricia Prichard', 'role': 'CONTACT', 'email': 'Patricia.Pritchard@nchmd.org', 'phone': '239-624-8120'}, {'name': 'Sharla Patterson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Naples Community Hospital', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '48307', 'city': 'Rochester', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Cribbs', 'role': 'CONTACT', 'email': 'michael.cribbs@ascension.org', 'phone': '248-652-5626'}, {'name': 'Colleen Ellis', 'role': 'CONTACT', 'email': 'Colleen.Ellis@ascension.org'}, {'name': 'Peter J. Littrup, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Julie Shultz, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ascension Crittenton Hospital', 'geoPoint': {'lat': 42.68059, 'lon': -83.13382}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sharon Steinberg, BS, RN, OCN', 'role': 'CONTACT', 'email': 'SteinbergS@MLHS.ORG', 'phone': '484-476-2395'}, {'name': 'Elene Turzo, MSN, CRNP', 'role': 'CONTACT', 'phone': '484-476-2649'}, {'name': 'Ned Z Carp, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jennifer L Sabol, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Robin Ciocca, D.O.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Lankenau Medical Center', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Liz Lorrell', 'role': 'CONTACT', 'email': 'emorrell@lifespan.org', 'phone': '401-444-2277'}, {'name': 'Robert Ward, M.D>', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '37909', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Miranda Stinnett', 'role': 'CONTACT', 'email': 'mstinnett@kcbc-center.com', 'phone': '865-583-1014'}, {'name': 'Kamilia Kozlowski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Caryn Wunderlich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Knoxville Comprehensive Breast Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '79416', 'city': 'Lubbock', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melanie Bisbee', 'role': 'CONTACT', 'email': 'Melanie.Bisbee@umchealthsystem.com', 'phone': '806-775-8597'}, {'name': 'Rakhshanda Rahman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '84405', 'city': 'Ogden', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joshua Kunz', 'role': 'CONTACT', 'email': 'joshua.kunz@mountainstarhealth.com', 'phone': '801-479-2067'}, {'name': 'Jose Tamayo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ogden Regional Hospital', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}], 'centralContacts': [{'name': 'Pamela Ellis', 'role': 'CONTACT', 'email': 'clinical@sanarus.com', 'phone': '(925) 460-6080'}], 'overallOfficials': [{'name': 'Dennis R. Holmes, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '90210 Surgery Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanarus Technologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}