Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT05698667
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2023-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outpatient Ultrasound for the Diagnostic Work-up of Oropharynx Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D014067', 'term': 'Tonsillar Neoplasms'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-02', 'studyFirstSubmitDate': '2023-01-16', 'studyFirstSubmitQcDate': '2023-01-16', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with oropharynx cancer detected by ultrasound compared to MRI', 'timeFrame': 'Within two weeks.', 'description': 'Patients with cancer (histopathology verified) correctly detected by a positive ultrasound or MRI test result.'}], 'secondaryOutcomes': [{'measure': 'Greatest tumor diameter compared between ultrasound and MRI.', 'timeFrame': '1 day', 'description': 'Greatest tumor diameter measured in millimeters.'}, {'measure': 'Proportion of patients without oropharynx cancer detected by ultrasound compared to MRI', 'timeFrame': 'Within three months.', 'description': 'Patients with benign tonsillar asymmetry (histopathology verified) correctly detected by a negative ultrasound or MRI test result.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oropharynx Cancer', 'Oropharynx Neoplasm', 'Tonsil Cancer', 'Tonsil Neoplasm', 'Tonsil Hypertrophy', 'Tonsil Lymphoma', 'Base of Tongue Tumor', 'Base of Tongue Carcinoma']}, 'descriptionModule': {'briefSummary': "The aim of the study was to examine the detection rate and tumor size evaluation in patients with suspected oropharynx cancer using a new technique with transoral ultrasound of the oropharynx. The new technique was compared to Magnetic Resonance Imaging (MRI). The study investigators included patients referred to a tertiary head \\& neck cancer center in Copenhagen, Denmark, with suspicion of oropharynx cancer. Patients supplied written informed consent and were included and ultrasound scanned with local anesthesia in the outpatient clinic. Blinded assessment of MRI's was performed for tumor detection and compared to ultrasound with the reference standard being histopathology biopsy results.", 'detailedDescription': 'An explorative diagnostic study was performed at the Department of Otorhinolaryngology, Head \\& Neck Surgery, Copenhagen University Hospital - Rigshospitalet, Denmark from October 1st, 2021, to April 30th, 2022. The study investigators invited adult patients from the outpatient cancer clinic referred with a suspicion of oropharynx cancer to participate in the study. At the study investigators\' center, all head \\& neck cancer patients receive diagnostic work-up which includes clinical exam, flexible laryngoscopy with narrow-band imaging, surgeon-performed neck ultrasound and biopsy and/or cytology with same-day results. Patients were enrolled after verbal and written consent and were offered an ultrasound examination of the oropharynx as an addition to the standard diagnostic workup in the outpatient clinic. All included patients also received an MRI of the head and neck. Clinical data including age, sex, smoking habits, alcohol consumption, date of MRI scan, and histopathology results were obtained from medical charts after inclusion.\n\nInterventions included transoral ultrasound of the tonsils and base of tongue, conducted with BK5000 ultrasound machines using the X18L5s "hockey stick" transducer. Transcervical ultrasound was also performed in patients where a tongue base cancer was most likely. Standard linear neck transducers (X18L5) or a curved 9C2 transducer was used. The tonsils and tongue base were scanned in two planes if possible, and doppler flow was recorded as well. Ultrasound images were stored as video clips.\n\nThe detection of tumors with ultrasound was recorded as "positive" if a well-defined tumor was seen that was clearly visualized compared to the contralateral side. A "negative" result was given if no tumors were suspected on either side. An "inconclusive" result was given if a tumor was not clear, but there was suspicious asymmetry visualized. The anatomical sub-location of tumors were stratified into right and left tonsil, tongue base, overlapping tonsil and tongue base, and "other" sub-locations. "Other" sub-locations included the soft palate, uvula, oropharynx posterior wall, vallecula, anterior pharyngeal arch and posterior pharyngeal arch.\n\nMRI was used as the reference test. An expert neuroradiologist blinded to ultrasound results and histopathology rated all tests for tumor detection in the oropharynx and tumor size in detected tumors.\n\nStatistical analysis:\n\nTumor detection of oropharynx ultrasound and MRI will be compared using the histopathologic diagnosis (cancer or benign) as reference standard to calculate sensitivity, specificity, positive- and negative predictive values (PPV, NPV).\n\nInconclusive tests will be analyzed as a positive result due to the clinical consequences often leading to diagnostic tonsillectomy.\n\nMcNemar\'s test for differences between sensitivity, specificity, PPV and NPV between ultrasound and MRI will be calculated.\n\nThe greatest tumor diameter will be compared between ultrasound and MRI using scatter plots and the Pearson\'s R correlation coefficient. Tumor volumes calculated using the formula for an ellipse: π/6 \\* craniocaudal \\* anteroposterior \\* mediolateral will be compared. Statistical analysis will be performed using R software version 4.2.2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (any of the following):\n\n* Visible and/or palpable tumor or asymmetry of the tonsils, tongue base or oropharynx.\n* Subjective symptoms of oropharynx cancer including dysphagia, odynophagia and/or referred otalgia.\n\nExclusion Criteria:\n\n* Unable to understand Danish or English.\n* Unable to provide written informed consent.\n* Age younger than 18 years.'}, 'identificationModule': {'nctId': 'NCT05698667', 'briefTitle': 'Outpatient Ultrasound for the Diagnostic Work-up of Oropharynx Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Surgeon-performed Outpatient Transoral and Transcervical Ultrasound for the Diagnostic Work-up of Oropharynx Cancer: a Feasibility Study', 'orgStudyIdInfo': {'id': 'Transoral US Feasibility'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oropharynx Ultrasound', 'description': 'Transoral and transcervical ultrasound of the oropharynx, including the tonsils and tongue base.', 'interventionNames': ['Diagnostic Test: Transoral ultrasound', 'Diagnostic Test: Transcervical ultrasound']}], 'interventions': [{'name': 'Transoral ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Under local anesthetic with xylocaine spray in the oropharynx, the tonsils and tongue base are scanned with small-footprint, high-frequency ultrasound transducers (such as the 18XL5s hockey-stick from BK Medical)', 'armGroupLabels': ['Oropharynx Ultrasound']}, {'name': 'Transcervical ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'The tongue base and tonsils are scanned externally via the neck, where a (preferably low-frequency) transducer is placed onto the skin above the hyoid bone to visualize the tongue base. The tonsils are visualized adjacent to the tongue base on either side and are located deep to the submandibular glands in a oblique coronal plane.', 'armGroupLabels': ['Oropharynx Ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Otorhinolaryngology, Head & Neck Surgery & Audiology', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Tobias Todsen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Novo Nordic Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Martin Garset-Zamani, MD', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}