Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-03 @ 2:06 PM
Study NCT ID:
NCT04080505
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2019-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006111', 'term': 'Graves Disease'}], 'ancestors': [{'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011193', 'term': 'Potassium Iodide'}], 'ancestors': [{'id': 'D007454', 'term': 'Iodides'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017680', 'term': 'Potassium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhk2029@cumc.columbia.edu', 'phone': '212-305-6969', 'title': 'Jennifer Kuo, MD', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '7 days', 'eventGroups': [{'id': 'EG000', 'title': 'SSKI (Potassium Iodide)', 'description': 'Participants randomized to receive 7 days of pre-operative SSKI\n\nSSKI- Potassium Iodide: 1g/mL, 2 drops orally 3 times a day for 7 days before surgery', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No SSKI', 'description': 'Participants randomized to not receive any drug pre-operative', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Vascular Flow From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SSKI (Potassium Iodide)', 'description': 'Participants randomized to receive 7 days of pre-operative SSKI\n\nSSKI- Potassium Iodide: 1g/mL, 2 drops orally 3 times a day for 7 days before surgery'}, {'id': 'OG001', 'title': 'No SSKI', 'description': 'Participants randomized to not receive any drug pre-operative'}], 'timeFrame': 'From Baseline to Immediately Before Surgery', 'description': 'Using 3D imaging software, the investigators will quantify the vascular flow in the ultrasound images and compare baseline images with the operating room (OR) images to assess if there is a difference in vascular flow between those timepoints. Vascular flow will be quantified using percent (%) surface area. This calculation will be done by a computer algorithm.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected and therefore cannot be analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SSKI (Potassium Iodide)', 'description': 'Participants randomized to receive 7 days of pre-operative SSKI\n\nSSKI- Potassium Iodide: 1g/mL, 2 drops orally 3 times a day for 7 days before surgery'}, {'id': 'FG001', 'title': 'No SSKI', 'description': 'Participants randomized to not receive any drug pre-operative'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '2 participants withdrew from the study prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SSKI (Potassium Iodide)', 'description': 'Participants randomized to receive 7 days of pre-operative SSKI\n\nSSKI- Potassium Iodide: 1g/mL, 2 drops orally 3 times a day for 7 days before surgery'}, {'id': 'BG001', 'title': 'NO SSKI', 'description': 'Participants randomized to not receive any drug pre-operative'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White Non-Hispanic', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-02-23', 'size': 153408, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-07T14:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "All participants complete a baseline neck ultrasound no less than 7 days prior to surgery, to obtain vascular flow imaging. Participants are then randomized to receive 7 days of pre-operative SSKI or not receive any drug. In the practice at Columbia, all patients with Graves' disease receive SSKI preoperatively, though this is not standard practice across the country, thus the 'no drug' group is experimental for research.\n\nAll participants complete a second ultrasound on the operating table before surgery, to assess for change in vascularity (experimental, as not all patients receive intra-operative ultrasounds before surgery). Both ultrasounds are performed by the surgeon."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'Low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2019-09-04', 'resultsFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2019-09-04', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-03', 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Vascular Flow From Baseline', 'timeFrame': 'From Baseline to Immediately Before Surgery', 'description': 'Using 3D imaging software, the investigators will quantify the vascular flow in the ultrasound images and compare baseline images with the operating room (OR) images to assess if there is a difference in vascular flow between those timepoints. Vascular flow will be quantified using percent (%) surface area. This calculation will be done by a computer algorithm.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Graves Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this research is to find out if SSKI (Potassium Iodide) reduces vascularity (the number and concentration of blood vessels) and improves how well patients do after surgery for removal of their whole thyroid gland in Graves' disease (an autoimmune disease that is a common cause of hyperthyroidism).", 'detailedDescription': "Patients with Graves' disease and goiters tend to have very vascular thyroid glands, which increases operative bleeding risks/rates. Many surgeons treat these patients with preoperative SSKI which is believed to decrease the vascularity, which in turn may decrease bleeding risks. However, there has been no quantitative data published on whether this is a real effect with true clinical benefit, in either animal or human models with SSKI. There have been some studies in Europe studying Lugol's solution, a different formulation of iodine, which show some decreased vascularity using color Doppler or measurements of CD34 cells."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* individuals diagnosed with Graves' disease undergoing total thyroidectomy for cure of disease.\n\nExclusion Criteria:\n\n* no Graves' disease\n* \\< 18 years old"}, 'identificationModule': {'nctId': 'NCT04080505', 'briefTitle': "Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy?", 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': "Does the Use of Pre-operative SSKI Actually Reduce Vascularity and Improve Surgical Outcomes for Total Thyroidectomy in Graves' Disease?", 'orgStudyIdInfo': {'id': 'AAAO3312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SSKI (Potassium Iodide)', 'description': 'Participants randomized to receive 7 days of pre-operative SSKI', 'interventionNames': ['Drug: SSKI- Potassium Iodide']}, {'type': 'NO_INTERVENTION', 'label': 'NO SSKI', 'description': 'Participants randomized to not receive any drug pre-operative'}], 'interventions': [{'name': 'SSKI- Potassium Iodide', 'type': 'DRUG', 'description': '1g/mL, 2 drops orally 3 times a day for 7 days before surgery', 'armGroupLabels': ['SSKI (Potassium Iodide)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jennifer Kuo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Jennifer Kuo', 'investigatorAffiliation': 'Columbia University'}}}}