Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
Study NCT ID:
NCT01153035
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-10
First Post:
2010-06-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Excision Followed by Radiofrequency Ablation for 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2010-06-24', 'studyFirstSubmitQcDate': '2010-06-28', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate the re-excision rate for close (<3mm) or positive margins', 'timeFrame': 'Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)', 'description': 'How many patients must go back for re-excision of margins'}, {'measure': 'Decrease local recurrence', 'timeFrame': 'Monitor throughout 5 year follow-up', 'description': 'The patient will be followed closely from the time of surgery through a period of 5 years in order to assess the frequency of local recurrence, defined as a new diagnosis of cancer at or near the site of primary surgery. It is our thought that the addition of RFA to the standard surgical treatment will reduce the number of local recurrences.'}]}, 'conditionsModule': {'keywords': ['Breast Conservation Therapy', 'Lumpectomy', 'Radiofrequency Ablation', 'Radiation'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24655863', 'type': 'BACKGROUND', 'citation': 'Klimberg VS, Ochoa D, Henry-Tillman R, Hardee M, Boneti C, Adkins LL, McCarthy M, Tummel E, Lee J, Malak S, Makhoul I, Korourian S. Long-term results of phase II ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial. J Am Coll Surg. 2014 Apr;218(4):741-9. doi: 10.1016/j.jamcollsurg.2013.12.032. Epub 2014 Jan 11.'}, {'pmid': '22422482', 'type': 'RESULT', 'citation': 'Mackey A, Feldman S, Vaz A, Durrant L, Seaton C, Klimberg VS. Radiofrequency ablation after breast lumpectomy added to extend intraoperative margins in the treatment of breast cancer (ABLATE): a single-institution experience. Ann Surg Oncol. 2012 Aug;19(8):2618-9. doi: 10.1245/s10434-012-2293-7. Epub 2012 Mar 16.'}, {'pmid': '22911363', 'type': 'RESULT', 'citation': 'Wilson M, Korourian S, Boneti C, Adkins L, Badgwell B, Lee J, Suzanne Klimberg V. Long-term results of excision followed by radiofrequency ablation as the sole means of local therapy for breast cancer. Ann Surg Oncol. 2012 Oct;19(10):3192-8. doi: 10.1245/s10434-012-2476-2. Epub 2012 Aug 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the "final" negative margin and consequently decrease the rates of re-operation. During the initial breast conservation procedure (lumpectomy), immediately following routine surgical resection of the tumor, radiofrequency energy (RFA) is applied to the wall (bed) of the fresh lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the resected specimen.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is a female, ≥ 50 years of age\n* The tumor size is ≤ 3 cm (on pre-study radiologic OR clinical exam)\n* The tumor is unicentric and unilateral\n* The tumor is not involving the skin\n* Pathology confirms ductal in situ (DCIS) OR infiltrating ductal carcinoma (IDC), grade I-III\n* If tumor is IDC, pathology must be hormone receptor positive (ER+ and/or PR+)\n* Patient signs current written informed consent and HIPAA forms\n\nExclusion Criteria:\n\n* Patient is under 50 years of age\n* Patient is male\n* Tumor \\> 3 cm in diameter\n* Bilateral malignancy\n* Clinically positive lymph nodes\n* Tumor involving the skin\n* Pathology confirms invasive lobular carcinoma\n* Breast implants\n* Less than 2 years disease-free survival from previous breast cancer\n* Neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years'}, 'identificationModule': {'nctId': 'NCT01153035', 'acronym': 'ABLATE', 'briefTitle': 'Excision Followed by Radiofrequency Ablation for Breast Cancer', 'nctIdAliases': ['NCT01420380'], 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer', 'orgStudyIdInfo': {'id': '104603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Surgery followed by RFA', 'interventionNames': ['Device: Radiofrequency Ablation']}], 'interventions': [{'name': 'Radiofrequency Ablation', 'type': 'DEVICE', 'otherNames': ['AngioDynamics, Inc.'], 'description': 'Breast conservation surgery followed by Radiofrequency Ablation of the cavity', 'armGroupLabels': ['Surgery followed by RFA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Oncology (Comprehensive Breast Care of San Diego)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Comprehensive Breast Care of Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'The University of Kansas Cancer Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Daniela Ochoa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Angiodynamics, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}