Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-01 @ 2:41 AM
Study NCT ID:
NCT06811532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Perfusion of Osteotomized Scapula and Lat Flap
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-01-31', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequacy of blood perfusion of osteomized lateral border of the scapula bone supplied by the angular artery', 'timeFrame': 'Intra-operatively', 'description': 'To measure the adequacy of blood perfusion of osteotomised lateral border of the scapula bone supplied by the angular artery via SPY-Q analysis in patients undergoing a scapular tip flap for reconstruction of a jaw defect'}, {'measure': 'Blood perfusion of osteomized lateral border of the scapula', 'timeFrame': 'Intra-operatively', 'description': 'To measure the adequacy of blood perfusion of osteotomised lateral border of the scapula bone supplied by the angular artery via SPY-Q analysis in patients undergoing a scapular tip flap for reconstruction of a jaw defect'}], 'secondaryOutcomes': [{'measure': 'To assess flap viability', 'timeFrame': 'Intra-operatively; up to 10 days post-operatively', 'description': 'To evaluate whether scapular tip flaps with an osteotomy with adequate bone perfusion scores resulted in surgical success (flap viability)'}, {'measure': 'Concordance between subjective and objective measure of blood perfusion', 'timeFrame': 'Intra-operatively; up to 10 days post-operatively', 'description': 'To assess the concordance between visual inspection of blood perfusion and SPY-Q analysis of blood perfusion'}, {'measure': 'Blood perfusion of latissmus dorsi', 'timeFrame': 'Intra-operatively', 'description': 'To measure the adequacy of blood perfusion of the latissimus dorsi muscle component of the scapula flap via SPY-Q analysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['head and neck cancer', 'scapular free flap', 'blood perfusion'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'The gold standard for reconstruction of the jaw is the utilization of a bone free tissue transfer. Scapula reconstruction is an excellent option for elderly patients, those with significant comorbidities and for complex defects with large soft tissue reconstructive requirements. The scapula is supplied by the angular artery and circumflex scapula arteries. No studies have shown with objective measures, the viability of the lateral border of the scapula bone supplied by either the angular artery or circumflex scapula arteries. The aim of this observational study is to demonstrate with objective clinical measures, via SPY-Q software analysis, that the angular artery can adequately supply the scapula tip flap including with a single osteotomy giving two bone segments, in 30 patients who will undergo reconstructive head and neck surgery at LHSC.', 'detailedDescription': 'The aim of this follow-up observational study is to demonstrate with objective clinical measures via SPY-Q software analysis, that the angular artery can adequately supply the scapula tip flap including a single distal osteotomy segment. 30 patients undergoing mandible or maxillary reconstruction with the scapular tip flap will be included. An osteotomy will be performed at up to 8cm from the scapular tip. The adequacy of blood supply to the scapula tip flap after a distal osteotomy and the latissimus dorsi muscle component of the flap will be measured intraoperatively, using SPY-Q software analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced head and neck cancer, benign tumors of the jaw and osteoradionecrosis, scheduled for head and neck reconstructive surgery using the scapular tip flap at London Health Sciences Centre (LHSC).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Adult patients (18 years and older) seen at the head and neck clinic at London Health Sciences Centre (LHSC)\n\n * Planned to undergo a maxillary and/or mandibular reconstruction surgery with a scapular tip flap\n\nExclusion Criteria:\n\n* • Younger than 18 years of age\n\n * History of failing microvascular flaps\n * Hypersensitivity toward ICG or related substances (e.g., imaging agents), defined as (based on ICG product monograph): possibly life-threatening dizziness, severe itching, hives, nausea, difficulty breathing, rash, low blood pressure)\n * Pregnant\n * Breastfeeding\n * Clinically apparent cognitive impairment'}, 'identificationModule': {'nctId': 'NCT06811532', 'briefTitle': 'Assessing Perfusion of Osteotomized Scapula and Lat Flap', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'officialTitle': 'Assessing Perfusion of an Osteotomised Scapula and Latissimus Dorsi Chimeric Free Flap on the Thoracodorsal Artery', 'orgStudyIdInfo': {'id': '126223'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood perfusion analysis using SPY-Q software', 'type': 'OTHER', 'description': 'Use of the SPY-Q analysis software during surgery to calculate bone profusion scores on several areas of the scapular tip flap (endosteum of scapula bone segments and latissimus dorsi muscle component).'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Agnieszka Dzioba, PhD', 'role': 'CONTACT', 'email': 'Agnieszka.Dzioba@lhsc.on.ca', 'phone': '519-685-8500'}], 'overallOfficials': [{'name': 'Danielle MacNeil, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Western University Canada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be made available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Danielle MacNeil', 'investigatorAffiliation': 'Western University, Canada'}}}}