Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-13 @ 12:48 PM
Study NCT ID:
NCT06431360
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007627', 'term': 'Keloid'}], 'ancestors': [{'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2024-05-22', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient and Observer Scar Assessment Scale (POSAS) scores', 'timeFrame': 'once every 3 months for 1 year after the last treatment', 'description': "The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.\n\ncomparable anatomic location."}, {'measure': 'Vancouver Scar Scale (VSS) scores', 'timeFrame': 'once every 3 months for 1 year after the last treatment', 'description': 'Physician evaluation comprised the use of the Vancouver Scar Scale (VSS) to evaluate the pigmentation (0=normal, 1=hypopigmented, 2=hyperpigmented), pliability (0=normal, 1= supple, 2=yielding, 3=firm, 4=banding, 5=contracture), height (0= flat, 1=5 mm), and vascularity (0=normal, 1=pink, 2=pink to red, 3=red, 4=red to purple, 5=purple).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Keloid']}, 'descriptionModule': {'briefSummary': 'Keloid patients were randomized into the experimental and control groups. Experimental group: Strontium-90 (Sr-90) brachytherapy followed by hyperthermia. Control group: Sr-90 brachytherapy alone .', 'detailedDescription': 'Sr-90 brachytherapy: 6-7 Gy each time, twice a week for 3 weeks; Hyperthermia: using a heater, 44℃ for 15 min'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient was clinically diagnosed with keloid, and the keloid area was clean without rupture and exudation；\n* Body surface keloid thickness: 2\\~5mm, diameter ≥10mm.\n\nExclusion Criteria:\n\n* Women who plan to become pregnant within 3 months or are pregnant or breastfeeding;\n* Patients with cicatricial constitution;\n* Abnormal coagulation function;\n* Patients who have received an adequate dose or course of radiation therapy;\n* People with previous immune system diseases, diabetes and other metabolic diseases.'}, 'identificationModule': {'nctId': 'NCT06431360', 'briefTitle': 'Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid', 'orgStudyIdInfo': {'id': 'KY20240514-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Sr-90 brachytherapy followed by hyperthermia.', 'interventionNames': ['Other: hyperthermia']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Sr-90 brachytherapy alone.'}], 'interventions': [{'name': 'hyperthermia', 'type': 'OTHER', 'otherNames': ['heater'], 'description': 'hyperthermia (using a heater, 44℃for 15 min)', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Wang, Ph.D.', 'role': 'CONTACT', 'email': 'fengwangcn@hotmail.com', 'phone': '86-025-52271455'}], 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Wang', 'role': 'CONTACT', 'email': 'fengwangcn@hotmail.com', 'phone': '86-025-52271455'}, {'name': 'Liang Shi', 'role': 'CONTACT', 'email': 'liangshi@njmu.edu.cn', 'phone': '86-025-52271491'}], 'facility': 'The First Affiliated Hospital of Nanjing Medical Univerity', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Feng Wang', 'role': 'CONTACT', 'email': 'fengwangcn@hotmail.com', 'phone': '86-025-52271455'}, {'name': 'Liang Shi', 'role': 'CONTACT', 'email': 'liangshi@njmu.edu.cn', 'phone': '86-025-52271491'}], 'overallOfficials': [{'name': 'Feng Wang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nanjing First Hospital, Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of nuclear medicine department', 'investigatorFullName': 'Feng Wang', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}