Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT03969108
Status:
COMPLETED
Last Update Posted:
2020-03-27
First Post:
2019-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D007011', 'term': 'Hypoparathyroidism'}], 'ancestors': [{'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'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-26', 'studyFirstSubmitDate': '2019-05-24', 'studyFirstSubmitQcDate': '2019-05-28', 'lastUpdatePostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantification of the fluorescent signal of ICG', 'timeFrame': 'At time of surgery', 'description': 'Quantification of the fluorescent signal of ICG'}], 'secondaryOutcomes': [{'measure': 'Appearance of parathyroid gland', 'timeFrame': 'At time of surgery', 'description': 'Vascularization appearance of parathyroid gland intraoperatively (1= surgeon thinks parathyroid gland is well vascularized, 2 = surgeons thinks parathyroid gland is devascularized)'}, {'measure': 'Duration of surgery', 'timeFrame': 'From start to end of surgery', 'description': 'Duration of surgery in minutes'}, {'measure': 'Postoperative calcium concentration', 'timeFrame': 'Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)', 'description': 'Postoperative albumin-corrected calcium concentration in blood'}, {'measure': 'Postoperative PTH concentration', 'timeFrame': 'Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)', 'description': 'Postoperative PTH concentration in blood'}, {'measure': 'Rate of prescribed postoperative calcium medication', 'timeFrame': 'Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)', 'description': 'Rate of prescribed postoperative calcium medication'}, {'measure': 'Rate of prescribed postoperative vitamin D medication', 'timeFrame': 'Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)', 'description': 'Rate of prescribed postoperative vitamin D medication'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroid surgery', 'Indocyanine green (ICG)', 'Hypoparathyroidism'], 'conditions': ['Thyroid Cancer', 'Thyroid Goiter', 'Graves Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy, including quantitative evaluations of the fluorescent signal. Therefore, patients will undergo thyroid surgery (total thyroidectomy) with the use of ICG fluorescence.', 'detailedDescription': 'Background Thyroid surgery volume continues to increase worldwide over the past few decades. During a total thyroidectomy (TTx), the ultimate goal is to remove all thyroid tissue, whereas damage to adjacent tissue is prevented. However, iatrogenic hypoparathyroidism, as a result of surgical removal or damage to the parathyroid glands, occurs in approximately 30% of the cases. In 2016 near-infrared fluorescence guided surgery with indocyanine green (ICG) was proposed for visualizing viability and blood supply of parathyroid glands during TTx. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins once in the bloodstream, and circulates in the intravascular compartment only. However, one of the limitations of ICG imaging is the subjectivity of the interpretation of fluorescence, which makes the assessment of images inconsistent among studies. There is a clear need for standardization of the evaluation of the perfusion with ICG, since visual evaluation of the fluorescent signal of ICG is not sufficient to reliably predict the perfusion of parathyroid glands.\n\nMain research question To develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy including quantitative evaluations of the fluorescent signal.\n\nDesign This will be a proof-of-concept , prospective cohort study of patients undergoing a total thyroidectomy with ICG-guided fluorescent surgery to evaluate tissue perfusion The main study endpoint is quantification of the fluorescent signal of ICG. Secondary outcomes are data from surgery, postoperative lab values (including calcium, PTH, albumin) and postoperative medication use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients ≥ 18 years\n2. Patients undergoing total thyroidectomy as surgical procedure for thyroid cancer, Graves' disease or goiter\n3. Patients are eligible for surgery\n4. Patients are mentally competent and are able and willing to comply with study procedures\n5. Written informed consent\n\nExclusion Criteria:\n\n1. Patients with a known allergy to ICG or iodinated contrast\n2. Pregnant or lactating women\n3. Patients with previous neck surgery"}, 'identificationModule': {'nctId': 'NCT03969108', 'briefTitle': 'Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment', 'orgStudyIdInfo': {'id': '19-5447'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indocyanine Green', 'interventionNames': ['Drug: Indocyanine Green']}], 'interventions': [{'name': 'Indocyanine Green', 'type': 'DRUG', 'description': 'ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.', 'armGroupLabels': ['Indocyanine Green']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jesse Pasternak, MD, MPHc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}