Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-27 @ 10:39 PM
Study NCT ID:
NCT05765695
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016606', 'term': 'Thyroid Nodule'}], 'ancestors': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-03-09', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thyroid nodule volume reduction rate', 'timeFrame': '1 month after the procedure', 'description': 'The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline'}, {'measure': 'Thyroid nodule volume reduction rate', 'timeFrame': '6 months after the procedure', 'description': 'The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline'}, {'measure': 'Thyroid nodule volume reduction rate', 'timeFrame': '12 months after the procedure', 'description': 'The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline'}, {'measure': 'Complication rate', 'timeFrame': 'When the procedure is performed', 'description': 'Assessment of the complications of the procedure and over time'}, {'measure': 'Complication rate', 'timeFrame': '1 month after the procedure', 'description': 'Assessment of the complications of the procedure and over time'}, {'measure': 'Complication rate', 'timeFrame': '6 months after the procedure', 'description': 'Assessment of the complications of the procedure and over time'}, {'measure': 'Complication rate', 'timeFrame': '12 months after the procedure', 'description': 'Assessment of the complications of the procedure and over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thyroid nodule', 'indeterminate', 'genetic', 'radiofrequency ablation', 'follow-up'], 'conditions': ['Thyroid Nodule']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to demonstrate that TIR3A nodules with negative genetic test can be safely and effectively treated by radiofrequency ablation, with nodular shrinkage and improvement of clinical symptoms.\n\nFine needle aspiration cytology is the gold standard test for differential diagnosis of thyroid nodules, but sometimes the result can be indeterminate with a risk of malignancy of 10-30%. In these cases the ablation is not indicated and many patients with benign nodules that may benefit from the procedure are not treated.\n\nAll the patients enrolled must have a TIR3A cytology and negative genetic test for mutations associated with thyroid carcinoma. Before the ablation blood, evaluation of serum TSH, anti-thyroglobulin antibodies, anti-thyroid peroxidase antibodies and calcitonin levels will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with thyroid nodule eligible for radiofrequency ablation, with low-risk indeterminate lesion cytology (TIR3A) and negative genetic test for mutations associated with thyroid carcinoma\n\nExclusion Criteria:\n\n* Patients who are not able to sign the informed consent\n* Patients with contraindications to radiofrequency ablation\n* Patients with cytology different from TIR3A\n* Patients with positive genetic test for mutations associated with thyroid carcinoma'}, 'identificationModule': {'nctId': 'NCT05765695', 'briefTitle': 'Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Radiofrequency Ablation for Treating Thyroid Nodules Classified as TIR3A, With a Negative Genetic Evaluation for Thyroid Carcinoma', 'orgStudyIdInfo': {'id': '05C023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated group', 'interventionNames': ['Procedure: Radiofrequency ablation performed with a 19 gauge STARmed needle.']}], 'interventions': [{'name': 'Radiofrequency ablation performed with a 19 gauge STARmed needle.', 'type': 'PROCEDURE', 'description': 'The ablation with radiofrequency is a safe and effective minimally invasive procedure that results in thermal tissue necrosis. A needle electrode is inserted into the thyroid nodule using ultrasound guidance and generates heat by alternating electric current causing thermal injury. Afterwards, the ablated tissue is gradually absorbed with progressive shrinkage of the nodule.', 'armGroupLabels': ['Treated group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20149', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Laura Fugazzola', 'role': 'CONTACT', 'email': 'l.fugazzola@auxologico.it', 'phone': '+390261911', 'phoneExt': '2727'}], 'facility': 'Istituto Auxologico Italiano IRCCS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Laura Fugazzola', 'role': 'CONTACT', 'email': 'l.fugazzola@auxologico.it', 'phone': '+390261911', 'phoneExt': '2727'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}