Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-30 @ 12:50 PM
Study NCT ID:
NCT04193332
Status:
UNKNOWN
Last Update Posted:
2022-02-14
First Post:
2019-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006996', 'term': 'Hypocalcemia'}], 'ancestors': [{'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 214}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-31', 'studyFirstSubmitDate': '2019-12-06', 'studyFirstSubmitQcDate': '2019-12-06', 'lastUpdatePostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative hypoparathyroidism', 'timeFrame': '24 months-follow-up', 'description': 'Hypoparathyroidism defined as: PTH \\< 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline'}], 'secondaryOutcomes': [{'measure': 'Postoperative hypocalcemia', 'timeFrame': '12 months follow-up', 'description': 'Hypocalcemia defined as: ionized Calcium \\< 1,15 mmol/L'}, {'measure': 'Time', 'timeFrame': 'Immediately after surgery', 'description': 'Duration of surgery'}, {'measure': 'Parathyroidglands identified by NIR light', 'timeFrame': 'During surgery', 'description': 'Number of identified by NIR light vs. white light'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thyroide surgery', 'total thyroidectomy', 'compltion thyroidectomy', 'parathyroidectomy', 'autofluorescense', 'NIR', 'near-infrared', 'optical imaging'], 'conditions': ['Hypoparathyroidism Postprocedural', 'Hypocalcemia', 'Surgery--Complications']}, 'referencesModule': {'references': [{'pmid': '30527238', 'type': 'BACKGROUND', 'citation': 'Abbaci M, De Leeuw F, Breuskin I, Casiraghi O, Lakhdar AB, Ghanem W, Laplace-Builhe C, Hartl D. Parathyroid gland management using optical technologies during thyroidectomy or parathyroidectomy: A systematic review. Oral Oncol. 2018 Dec;87:186-196. doi: 10.1016/j.oraloncology.2018.11.011. Epub 2018 Nov 16.'}, {'pmid': '30710614', 'type': 'BACKGROUND', 'citation': 'Dip F, Falco J, Verna S, Prunello M, Loccisano M, Quadri P, White K, Rosenthal R. Randomized Controlled Trial Comparing White Light with Near-Infrared Autofluorescence for Parathyroid Gland Identification During Total Thyroidectomy. J Am Coll Surg. 2019 May;228(5):744-751. doi: 10.1016/j.jamcollsurg.2018.12.044. Epub 2019 Jan 31.'}, {'pmid': '29122325', 'type': 'BACKGROUND', 'citation': 'Benmiloud F, Rebaudet S, Varoquaux A, Penaranda G, Bannier M, Denizot A. Impact of autofluorescence-based identification of parathyroids during total thyroidectomy on postoperative hypocalcemia: a before and after controlled study. Surgery. 2018 Jan;163(1):23-30. doi: 10.1016/j.surg.2017.06.022. Epub 2017 Nov 6.'}, {'pmid': '36853388', 'type': 'DERIVED', 'citation': 'Lykke E, Christensen A, Juhl K, Feldt-Rasmussen U, Friberg Hitz M, Svenningsen Sjostedt SM, Holst Hahn C, Kraik Svensson DM, Kanstrup Springborg K, Stage MG, Bjorn Hvilsom G, Hilsted LM, Dahl M, Lelkaitis G, Kjaer A, Homoe P, von Buchwald C. Effect of near infrared autofluorescence guided total thyroidectomy on postoperative hypoparathyroidism: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2023 May;280(5):2593-2603. doi: 10.1007/s00405-023-07867-4. Epub 2023 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this ongoing randomized controlled trial is to examine whether the use of intra-operative NIR(near infrared) camera can reduce the number of patients who experience transient or persistent hypoparathyroidism after total thyroidectomy and completion thyroidectomy, both in malignant and benign thyroid disease.', 'detailedDescription': 'Patients admitted to total thyroidectomy or completion thyroidectomy is ramdomized to:\n\n1. Intervention: NIR optic imaging assisted identification of the parathyroid glands during thyroidectomy using parathyroid gland autofluorescence.\n2. Control: Conventional thyroidectomy and parathyroid identification by the surgeon.\n\nMeasurements:\n\nPTH and ionized-Ca blood samples are collected preoperatively, within 12 hours postoperatively and at 1-, 3-, 9- and 12-months follow-up.\n\nAnticipated 214 patients are included, all of which participate in 3 months follow-up. Only patients with persistent hypoparathyroidism at this point continue til maximum 12 months follow-up.\n\nAn interim analysis will be conducted when inclusion of anticipated 128 patients and 3 months follow-up is reached.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to understand patient information and to give written informed consent\n* Patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign.\n\nExclusion Criteria:\n\n* Not able to understand patient information and to give written informed consent\n* Previous parathyroid surgery or other parathyroid decease\n* Age under 18'}, 'identificationModule': {'nctId': 'NCT04193332', 'briefTitle': 'Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery Can Prevent Post-thyroidectomy Hypoparathyroidism', 'orgStudyIdInfo': {'id': 'H19010211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plus NIR optical imaging', 'description': 'NIR optical imaging assisted identification of parathyroid glands during thyroid surgery', 'interventionNames': ['Device: NIR optical imaging camera']}, {'type': 'NO_INTERVENTION', 'label': 'Minus NIR optical imaging', 'description': 'Conventional identification of parathyroid glands during thyroid surgery'}], 'interventions': [{'name': 'NIR optical imaging camera', 'type': 'DEVICE', 'description': 'NIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense', 'armGroupLabels': ['Plus NIR optical imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Eva Lykke, MD', 'role': 'CONTACT', 'email': 'eva.lykke@regionh.dk', 'phone': '+45 35454799'}, {'name': 'Christian on Buchwald, MDSc, PhD', 'role': 'CONTACT', 'email': 'christian.von.buchwald@regionh.dk', 'phone': '+45 35452370'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '4600', 'city': 'Køge', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Preben Homøe, DMSc, PhD', 'role': 'CONTACT', 'email': 'prho@regionsjaelland.dk', 'phone': '+45 56 63 15 00'}], 'facility': 'Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}], 'centralContacts': [{'name': 'Eva Lykke, MD', 'role': 'CONTACT', 'email': 'eva.lykke@regionh.dk', 'phone': '+45 35454799'}, {'name': 'Anders Christensen, MD, PhD', 'role': 'CONTACT', 'email': 'anders.christensen.03@regionh.dk', 'phone': '+45 35459786'}], 'overallOfficials': [{'name': 'Christian von Buchwald, MDSc, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cluster for molecular imaging, Denmark', 'class': 'UNKNOWN'}, {'name': 'Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Eva Lykke', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}