3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05843032
• Other study ID #: 21017915
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: May 2023
• Source: Rigshospitalet, Denmark
• Contact: Fatemeh Makouei, PhD
• Phone: +4550243760
• Email: fatemeh.makouei[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. completion date: February 15, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with biopsy-proven oral tongue squamous cell carcinoma scheduled for surgical treatment
• T1-T3 staging on cross-sectional imaging

Exclusion Criteria:

• T4 staging
• Unable to understand the verbal or written information
• Prior radiotherapy treatment of oral cavity cancer

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Squamous Cell Carcinoma
• Tongue SCC

Intervention

Diagnostic Test:
• 3D ultrasound, MRI, resected specimen examination by surgeon
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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of the 3D ultrasound and MRI compared to the conventional method in measurements of the surgical margins in the resected tongue SCC specimens.		2 weeks
Primary	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		2 weeks
Secondary	Number of cases requiring adjuvant treatments (surgery or chemo/radiotherapy)		2 weeks
Secondary	Shrinkage of the surgical specimen due to formalin fixation based on the specimen volume measurements on 3D ultrasound images before and after formalin fixation		2 weeks