Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-01-02 @ 12:03 PM
Study NCT ID:
NCT07140757
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency Ablation for Management of Benign/Indeterminate Thyroid Nodules and Low Risk Papillary Thyroid Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077273', 'term': 'Thyroid Cancer, Papillary'}], 'ancestors': [{'id': 'D000231', 'term': 'Adenocarcinoma, Papillary'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health- related Quality of Life Questionnaires', 'timeFrame': 'Through study completion; an average of 1 year', 'description': 'This questionnaire includes twenty-four questions covering patients complaints ranging from 0 to 4. Patients will be asked about the presence and severity of each item currently on the medical appointment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Risk', 'Papillary Thyroid Cancer', 'Radiofrequency Ablation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To track the outcomes of patients who have been treated with RFA and its long-term effectiveness, and to learn more about the quality of life of patients who have received RFA in this study.', 'detailedDescription': 'Primary Objectives\n\n• To evaluate thyroid nodule volume changes over time in participants undergoing RFA as part of clinical care\n\nSecondary Objectives\n\n* To establish the health-related quality of life among participants undergoing with ultrasound guided RFA.\n* To evaluate the sonographic features of thyroid nodules over time following ultrasound guided RFA.\n* To assess adverse events rates following ultrasound guided RFA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MD Anderson Cancer Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility Criteria\n\n1. Participants scheduled to undergo ultrasound-guided RFA for the following conditions: benign thyroid nodules, indeterminate thyroid nodules, low-risk DTC, and recurrent PTC\n2. Participant is over 18 years and is either not a surgical candidate or has declined surgery.\n3. Capable and willing to provide written informed consent\n4. Participant has one of the following diagnoses:\n\n * Biopsy-proven benign thyroid nodules causing compressive and/or cosmetic symptoms who are requesting treatment,\n * Biopsy-proven indeterminate nodules (AUS or follicular neoplasm)\n * Papillary thyroid carcinoma (PTC) without metastasis\n * Locally recurrent thyroid cancer (\\< 2 cm).\n\nExclusion Criteria\n\n1. Participants meeting any of the following criteria will be excluded:\n2. Participants considered unsuitable for RFA by the treating physician'}, 'identificationModule': {'nctId': 'NCT07140757', 'briefTitle': 'Radiofrequency Ablation for Management of Benign/Indeterminate Thyroid Nodules and Low Risk Papillary Thyroid Cancers', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Radiofrequency Ablation for Management of Benign/Indeterminate Thyroid Nodules and Low Risk Papillary Thyroid Cancers', 'orgStudyIdInfo': {'id': '2025-0083'}, 'secondaryIdInfos': [{'id': 'NCI-2025-06179', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Registry'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'This questionnaire includes twenty-four questions covering patients complaints ranging from 0 to 4. Patients will be asked about the presence and severity of each item currently on the medical appointment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victoria E Banuchi, MD', 'role': 'CONTACT', 'email': 'VEBanuchi@mdanderson.org', 'phone': '346-217-8668'}, {'name': 'Victoria E Banuchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Victoria E Banuchi, MD', 'role': 'CONTACT', 'email': 'vebanuchi@mdanderson.org', 'phone': '346-217-8668'}], 'overallOfficials': [{'name': 'Victoria E Banuchi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}