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NCT05740774 Clinical Trial

Surgical Margin Assessment by 3D Ultrasound

Head and Neck Cancer Clinical Trial

Official title:
Feasibility of 3D Ultrasound in the Assessment of Resection Margins During Surgery for Squamous Cell Carcinoma of the Tongue: a Comparison With Histopathology

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05740774
Other study ID # 21017915a
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date April 30, 2023

Study information
Verified date February 2023
Source Rigshospitalet, Denmark
Contact Fatemeh Makouei
Phone 50243760
Email fatemeh.makouei@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Complete removal of cancer encircled by a secure margin of healthy tissue is the aim of surgical oncology. A close or positive surgical margin reported by pathologist typically ends in adjuvant therapies (re-surgery and/or radiotherapy), which come with prognostic risks and financial cost. Therefore, ex-vivo imaging of removed cancer tissue may assist in margin evaluation. In this study, investigators aimed to investigate the correlation of 3D ultrasound to histopathology to assess tongue tumor margin status.

Recruitment information / eligibility
Status Recruiting
Enrollment 7
Est. completion date April 30, 2023
Est. primary completion date March 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-T2 staging on cross-sectional imaging Exclusion Criteria: - Age < 18 yrs - T3-T4 staging - Unable to understand the verbal or written information - Prior radiotherapy treatment of oral cavity cancer

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 3D ultrasound
3D ultrasound scanning of the resected tongue tumor will be performed. The margin analysis will be made using the 3D ultrasound image.

Locations
Country Name City State
Denmark Rigshospitalet København Ø Dk-015

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (8)

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

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 Correlation of the surgical margin measurements of the 3D ultrasound to histopathology The smallest margin will be measured in mm on 3D ultrasound image of the ex-vivo surgical specimen. Correlation of the measurement to the final histopathology result will be investigated. 2 weeks
Primary Diagnostic accuracy number of margins correctly classified as free (> 5 mm), close (< 5 mm) or positive (<1 mm) margin 2 weeks
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