Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-03-30 @ 8:36 PM
Study NCT ID:
NCT05843032
Status:
UNKNOWN
Last Update Posted:
2023-05-09
First Post:
2023-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-05', 'studyFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2023-04-24', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the 3D ultrasound and MRI compared to the conventional method in measurements of the surgical margins in the resected tongue SCC specimens.', 'timeFrame': '2 weeks'}, {'measure': 'Diagnostic accuracy - number of margins correctly classified as free (> 5 mm), close (1- 5 mm) or positive (<1 mm) margin by 3D ultrasound and MRI using histopathology findings as the reference', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of cases requiring adjuvant treatments (surgery or chemo/radiotherapy)', 'timeFrame': '2 weeks'}, {'measure': 'Shrinkage of the surgical specimen due to formalin fixation based on the specimen volume measurements on 3D ultrasound images before and after formalin fixation', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound', '3D ultrasound', 'Ultrasonography', 'Three dimensional imaging', 'cancer diagnosis', 'surgical margin assessment', 'magnetic resonance imaging', 'MRI', 'ex-vivo surgical specimen imaging', 'squamous cell carcinoma', 'histopathology', 'SCC', 'oral cancer'], 'conditions': ['Squamous Cell Carcinoma', 'Tongue SCC', 'Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '26351335', 'type': 'BACKGROUND', 'citation': 'Chinn SB, Myers JN. Oral Cavity Carcinoma: Current Management, Controversies, and Future Directions. J Clin Oncol. 2015 Oct 10;33(29):3269-76. doi: 10.1200/JCO.2015.61.2929. Epub 2015 Sep 8.'}, {'pmid': '33030524', 'type': 'BACKGROUND', 'citation': 'Pagedar NA. Better Visualization of Oral Cancer Margins-A Struggle of Cancer and Technology. JAMA Otolaryngol Head Neck Surg. 2020 Dec 1;146(12):1156-1157. doi: 10.1001/jamaoto.2020.3262. No abstract available.'}, {'pmid': '31695503', 'type': 'BACKGROUND', 'citation': 'Schmidt Jensen J, Jakobsen KK, Mirian C, Christensen JT, Schneider K, Nahavandipour A, Wingstrand VL, Wessel I, Tvedskov JF, Frisch T, Christensen A, Specht L, Andersen E, Lelkaitis G, Gronhoj C, von Buchwald C. The Copenhagen Oral Cavity Squamous Cell Carcinoma database: protocol and report on establishing a comprehensive oral cavity cancer database. Clin Epidemiol. 2019 Aug 19;11:733-741. doi: 10.2147/CLEP.S215399. eCollection 2019.'}, {'pmid': '33774501', 'type': 'BACKGROUND', 'citation': 'de Koning KJ, Koppes SA, de Bree R, Dankbaar JW, Willems SM, van Es RJJ, Noorlag R. Feasibility study of ultrasound-guided resection of tongue cancer with immediate specimen examination to improve margin control - Comparison with conventional treatment. Oral Oncol. 2021 May;116:105249. doi: 10.1016/j.oraloncology.2021.105249. Epub 2021 Mar 26.'}, {'pmid': '8745780', 'type': 'BACKGROUND', 'citation': 'Narayana HM, Panda NK, Mann SB, Katariya S, Vasishta RK. Ultrasound versus physical examination in staging carcinoma of the mobile tongue. J Laryngol Otol. 1996 Jan;110(1):43-7. doi: 10.1017/s0022215100132682.'}, {'pmid': '29362123', 'type': 'BACKGROUND', 'citation': 'Klein Nulent TJW, Noorlag R, Van Cann EM, Pameijer FA, Willems SM, Yesuratnam A, Rosenberg AJWP, de Bree R, van Es RJJ. Intraoral ultrasonography to measure tumor thickness of oral cancer: A systematic review and meta-analysis. Oral Oncol. 2018 Feb;77:29-36. doi: 10.1016/j.oraloncology.2017.12.007. Epub 2017 Dec 18.'}, {'pmid': '30151976', 'type': 'BACKGROUND', 'citation': 'Tarabichi O, Bulbul MG, Kanumuri VV, Faquin WC, Juliano AF, Cunnane ME, Varvares MA. Utility of intraoral ultrasound in managing oral tongue squamous cell carcinoma: Systematic review. Laryngoscope. 2019 Mar;129(3):662-670. doi: 10.1002/lary.27403. Epub 2018 Aug 27.'}, {'pmid': '35901543', 'type': 'BACKGROUND', 'citation': 'de Koning KJ, van Es RJJ, Klijn RJ, Breimer GE, Willem Dankbaar J, Braunius WW, van Cann EM, Dieleman FJ, Rijken JA, Tijink BM, de Bree R, Noorlag R. Application and accuracy of ultrasound-guided resections of tongue cancer. Oral Oncol. 2022 Oct;133:106023. doi: 10.1016/j.oraloncology.2022.106023. Epub 2022 Jul 25.'}, {'pmid': '36547494', 'type': 'BACKGROUND', 'citation': 'Makouei F, Ewertsen C, Agander TK, Olesen MV, Pakkenberg B, Todsen T. 3D Ultrasound versus Computed Tomography for Tumor Volume Measurement Compared to Gross Pathology-A Pilot Study on an Animal Model. J Imaging. 2022 Dec 19;8(12):329. doi: 10.3390/jimaging8120329.'}]}, 'descriptionModule': {'briefSummary': 'In the current protocol, application of 3D ex-vivo ultrasound, MRI, and clinical evaluation (palpation and examination) by the surgeon is proposed to analyze the margin status in tongue squamous cell carcinoma and correlate the results to the histopathology findings.', 'detailedDescription': 'Cancer surgery is the primary treatment in the early stages of tongue squamous cell carcinoma (SCC), and the goal is the complete resection of the tumor with an adequate margin of healthy tissue around to ensure proper cancer removal. Inadequate margins lead to a high risk of local cancer recurrence and the patient will need re-surgery or adjuvant therapies. Ex-vivo imaging of the resected surgical specimen has been suggested to provide information for margin assessment and thus improve cancer surgery. In this manuscript, a protocol to investigate the clinical benefit of three-dimensional (3D) ultrasound imaging of the surgical margins and comparing the results to magnetic resonance imaging (MRI) and the clinical examination of the surgical specimen by surgeon (palpation to inspect the resected tissue) has been designed. Tumor segmentation and margin measurement (Anterior towards apex of tongue, posterior towards base of tongue, medial towards back of tongue, lateral towards floor of mouth, and profound/deep margins) will be performed by head and neck surgeons on 3D ultrasound images and by two consultant radiologists on MRI of the ex-vivo specimen. Accuracy of each method will be evaluated by computing the proportion of correctly classified margins (positive, close, and free) by each technique with respect to the gold standard histopathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with biopsy-proven oral tongue squamous cell carcinoma scheduled for surgical treatment\n* T1-T3 staging on cross-sectional imaging\n\nExclusion Criteria:\n\n* T4 staging\n* Unable to understand the verbal or written information\n* Prior radiotherapy treatment of oral cavity cancer'}, 'identificationModule': {'nctId': 'NCT05843032', 'briefTitle': '3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': '3D Ultrasound in the Assessment of Resection Margins During Surgery for Squamous Cell Carcinoma of the Tongue: a Comparison With Clinical Evaluation, MRI, and Histopathology', 'orgStudyIdInfo': {'id': '21017915'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tongue tumor resection', 'interventionNames': ['Diagnostic Test: 3D ultrasound, MRI, resected specimen examination by surgeon']}], 'interventions': [{'name': '3D ultrasound, MRI, resected specimen examination by surgeon', 'type': 'DIAGNOSTIC_TEST', 'description': '3D ultrasound and MR scanning of the resected tongue tumor will be performed. The resected surgical specimen will also be examined by the surgeon to assess the margins. The accuracy of the margin assessment by 3D ultrasound, MRI, and surgeon examination will be evaluated by correlating the results to the final histopathology findings.', 'armGroupLabels': ['Tongue tumor resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Capital Region', 'country': 'Denmark', 'contacts': [{'name': 'Tobias Todsen, MD, PhD', 'role': 'CONTACT', 'email': 'tobias.todsen@regionh.dk', 'phone': '+4535452071'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Fatemeh Makouei, PhD', 'role': 'CONTACT', 'email': 'fatemeh.makouei@regionh.dk', 'phone': '+4550243760'}, {'name': 'Tobias Todsen, MD, PhD', 'role': 'CONTACT', 'email': 'tobias.todsen@regionh.dk', 'phone': '+4535452071'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Available for 5 years', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Biomedical Engineer, PhD, Assistant professor', 'investigatorFullName': 'Fatemeh Makouei', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}