Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-04 @ 3:21 AM
Study NCT ID:
NCT06716892
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2024-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Preoperative Tissue Evaluation in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'whole blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-29', 'studyFirstSubmitDate': '2024-11-29', 'studyFirstSubmitQcDate': '2024-11-29', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle oxygenation (in arbitrary units)', 'timeFrame': 'Immediately before and after intervention (exercise) within both cohorts. Within the cohort of head and neck tumor patients, possible postoperative second measurement of the transplanted tissue after performed reconstructive surgery.', 'description': 'Oxygenated hemoglobin signal in the measured muscle regions in all different cohorts.'}, {'measure': 'Quantitative hemoglobin-associated signal (in arbitrary units)', 'timeFrame': 'Immediately before and after intervention (exercise) within both cohorts. Within the cohort of head and neck tumor patients, possible postoperative second measurement of the transplanted tissue after performed reconstructive surgery.', 'description': 'Hemoglobin signal in the measured muscle regions in all different cohorts.'}], 'secondaryOutcomes': [{'measure': 'Postoperative compromise of microvascular free flaps (Microvascular revision, flap failure)', 'timeFrame': 'Postoperative observation of the free flap within the stationary visit until dismission (14 days)', 'description': 'Correlation between preoperative accquired MSOT parameters (e.g. quantitative hemoglobin-associated signal, muscle oxygenation, oxygen saturation) in the head and neck cancer cohort and the clinical outcome of the reconstructive surgery (Microvascular revision, flap failure).'}, {'measure': 'Oxygen saturation (in %)', 'timeFrame': 'Immediately before and after intervention (exercise) within both cohorts. Within the cohort of head and neck tumor patients, possible postoperative second measurement of the transplanted tissue after performed reconstructive surgery.', 'description': 'Proportion of oxygenated hemoglobin signal compared with total hemoglobin signal in the measured muscle regions in all different cohorts'}, {'measure': 'Questionnaire items (Age, sex, height, weight, BMI, skin type, pre-existing conditions, medication, substance abuse [alcohol, nicotine], moderate physical activity per week)', 'timeFrame': 'Once at the date of inclusion for the study.', 'description': 'Questionnaire items for both the healthy and the head and neck tumor cohort.'}, {'measure': 'Muscle oxygenation (in arbitrary units)', 'timeFrame': 'Immediately before and after intervention (exercise) within both cohorts. Within the cohort of head and neck tumor patients, possible postoperative second measurement of the transplanted tissue after performed reconstructive surgery.', 'description': 'Oxygenated hemoglobin signal in the measured muscle regions in all different cohorts.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MSOT', 'Head and neck cancer', 'healthy', 'flap surgery', 'graft', 'perfusion', 'oxygenation'], 'conditions': ['Head and Neck Cancer', 'Healthy']}, 'descriptionModule': {'briefSummary': 'Multispectral Optoacoustic Tomography (MSOT) is a promising imaging technology that utilizes pulsed laser light. One of the key capabilities of this technology is measuring oxygenation within human tissue. This proposed study aims to investigate possible limitations of human tissue used for reconstructive surgery due to flawed tissue perfusion.\n\nHealthy volunteers as well as patients with a diagnosed head and neck cancer entity will be recruited. Both cohorts will then be scanned on different body areas (most common tissue sites used for reconstructive surgery on the back, arms and legs) to assess differences in muscle oxygenation between the healthy and tumor patient cohort using MSOT.\n\nThe hypothesis of the study is, that patients with diagnosed head and neck cancer entities are prone to compromised tissue perfusion due to a high prevalence of smoking within the head neck tumor patient cohort and therefore perfusion restirciting diseases e.g. peripheral arterial occlusive disease (PAOD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible subjects are Histopathological diagnosed head and neck tumor patients of the cmf department of the University clinic of erlangen (1) and healthy volunteers who will be recruited from advertised announcements (2).\n\nAll subjects meeting all inclusion and none of the exclusion criteria will be enrolled and added to their corresponding cohort (1 or 2).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cohort 1: Histopathological diagnosed head and neck tumor patients.\n* Cohort 2: Healthy adults.\n\nExclusion Criteria:\n\n* Pregnancy / breastfeeding\n* ink / tattoo in the areas of interest (upper back, distal forearm, upper and lower leg)\n* missing consent form\n* Cohort 2: Chronical abuse of alcohol and nicotine.'}, 'identificationModule': {'nctId': 'NCT06716892', 'acronym': 'msotcmfflap', 'briefTitle': 'Non-invasive Preoperative Tissue Evaluation in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Non-invasive Preoperative Donor-site Evaluation of Free Flaps in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)', 'orgStudyIdInfo': {'id': '24-335-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'description': 'Healthy adult volunteers. Exclusion criteria: Chronical abuse of alcohol and nicotine, pregnancy and breastfeeding, ink / tattoo in the areas of interest (upper back, distal forearm, upper and lower leg)', 'interventionNames': ['Device: Multispectral Optoacoustic Tomography (MSOT)']}, {'label': 'Head and neck cancer patients.', 'description': 'Patients with histopathological diagnosed head and neck cancer.', 'interventionNames': ['Device: Multispectral Optoacoustic Tomography (MSOT)']}], 'interventions': [{'name': 'Multispectral Optoacoustic Tomography (MSOT)', 'type': 'DEVICE', 'description': 'Non-invasive transcutaneous MSOT imaging of muscle and subcutaneos regions.', 'armGroupLabels': ['Head and neck cancer patients.', 'Healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Felix Wachter', 'role': 'CONTACT', 'email': 'felix.wachter@uk-erlangen.de', 'phone': '+49 9131 85 41175'}, {'name': 'Jonas Wolf, Dr. med.', 'role': 'CONTACT', 'email': 'jonas.wolf@uk-erlangen.de', 'phone': '+49 9131 85 43770'}], 'facility': 'University Hospital Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'centralContacts': [{'name': 'Felix Wachter', 'role': 'CONTACT', 'email': 'felix.wachter@uk-erlangen.de', 'phone': '+49 9131 85 41175'}, {'name': 'Jonas Wolf, Dr. med.', 'role': 'CONTACT', 'email': 'jonas.wolf@uk-erlangen.de', 'phone': '+49 9131 85 43770'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to the big amounts of acquired image data a publishing is not feasable.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}