Ultrasound in Tongue Cancer- a Help to Decide Depth of Invasion and to Improve the Surgical Margin

NCT04059861 | Completed

• 1 other identifier: 252891
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate if ultrasound can be helpful in the diagnostic work-up of oral tongue and floor of the mouth cancer. One important factor is how deeply the tumour invades the tissue, the so called depth of invasion (DOI). The investigator will measure DOI with ultrasound and compare the result with the same measurement by magnetic resonance imaging and the microscopic result after the surgery (PAD). Ultrasound will also be used during surgery of the tumour to investigate if it is useful to better decide the depth of the tumour and thereby improving the operation.

Conditions

Tongue Cancer; Floor of Mouth Squamous Cell Carcinoma

Keywords

ultrasound; depth of invasion; tongue cancer; floor of the mouth cancer; resection margin; thickness; tongue carcinoma; tongue neoplasm; cancer of the tongue

Outcome Measures

Primary Outcomes (2)

• Depth of invasion

  Depth of invasion in millimeters measured by ultrasound compared to Clinical palpation , MRI and PAD.

  up to 6 weeks.

• Intraoperative ultrasound helpful during surgery

  Comparison of surgical margins in resections done with and without the assistance of ultrasound.

  up to 6 weeks.

Study Arms (1)

ultrasound assisted resection

OTHER

resection of tongue cancer will be done with assistance of ultrasound to visualise the deep margin.

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

enrolled patients will be investigated by ultrasound two times, awake in the clinic and in narcosis before the surgery. For those with tongue cancer ultrasound will be used during the surgery to visualise the deep margin of the tumour.

ultrasound assisted resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• biopsy verified tongue cancer or floor of the mouth cancer. International Statistical Classification of Diseases and Related Health Problems (ICD) 10 C02.0-2 or C04.0-1

You may not qualify if:

• former surgery in the oral cavity
• former radiation to the oral cavity
• floor of the mouth cancer not available to ultrasound investigation
• floor of the mouth cancer extending to the gingiva
• patients not suitable for surgery
• T4 tumours according to TNM 8
• age under 18
• patients declining to participate

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Örebro University Hospital

Örebro, 70185, Sweden

Location

Related Publications (10)

• Baek CH, Son YI, Jeong HS, Chung MK, Park KN, Ko YH, Kim HJ. Intraoral sonography-assisted resection of T1-2 tongue cancer for adequate deep resection. Otolaryngol Head Neck Surg. 2008 Dec;139(6):805-10. doi: 10.1016/j.otohns.2008.09.017.

  PMID: 19041507 BACKGROUND

• Kodama M, Khanal A, Habu M, Iwanaga K, Yoshioka I, Tanaka T, Morimoto Y, Tominaga K. Ultrasonography for intraoperative determination of tumor thickness and resection margin in tongue carcinomas. J Oral Maxillofac Surg. 2010 Aug;68(8):1746-52. doi: 10.1016/j.joms.2009.07.110. Epub 2009 Dec 23.

  PMID: 20031291 BACKGROUND

• Tarabichi O, Kanumuri V, Juliano AF, Faquin WC, Cunnane ME, Varvares MA. Intraoperative Ultrasound in Oral Tongue Cancer Resection: Feasibility Study and Early Outcomes. Otolaryngol Head Neck Surg. 2018 Apr;158(4):645-648. doi: 10.1177/0194599817742856. Epub 2017 Nov 21.

  PMID: 29161194 BACKGROUND

• Lydiatt WM, Patel SG, O'Sullivan B, Brandwein MS, Ridge JA, Migliacci JC, Loomis AM, Shah JP. Head and Neck cancers-major changes in the American Joint Committee on cancer eighth edition cancer staging manual. CA Cancer J Clin. 2017 Mar;67(2):122-137. doi: 10.3322/caac.21389. Epub 2017 Jan 27.

  PMID: 28128848 BACKGROUND

• International Consortium for Outcome Research (ICOR) in Head and Neck Cancer; Ebrahimi A, Gil Z, Amit M, Yen TC, Liao CT, Chaturvedi P, Agarwal JP, Kowalski LP, Kreppel M, Cernea CR, Brandao J, Bachar G, Bolzoni Villaret A, Fliss D, Fridman E, Robbins KT, Shah JP, Patel SG, Clark JR. Primary tumor staging for oral cancer and a proposed modification incorporating depth of invasion: an international multicenter retrospective study. JAMA Otolaryngol Head Neck Surg. 2014 Dec;140(12):1138-48. doi: 10.1001/jamaoto.2014.1548.

  PMID: 25075712 BACKGROUND

• Lam P, Au-Yeung KM, Cheng PW, Wei WI, Yuen AP, Trendell-Smith N, Li JH, Li R. Correlating MRI and histologic tumor thickness in the assessment of oral tongue cancer. AJR Am J Roentgenol. 2004 Mar;182(3):803-8. doi: 10.2214/ajr.182.3.1820803.

  PMID: 14975989 BACKGROUND

• Yesuratnam A, Wiesenfeld D, Tsui A, Iseli TA, Hoorn SV, Ang MT, Guiney A, Phal PM. Preoperative evaluation of oral tongue squamous cell carcinoma with intraoral ultrasound and magnetic resonance imaging-comparison with histopathological tumour thickness and accuracy in guiding patient management. Int J Oral Maxillofac Surg. 2014 Jul;43(7):787-94. doi: 10.1016/j.ijom.2013.12.009. Epub 2014 Mar 2.

  PMID: 24598430 BACKGROUND

• Alsaffar HA, Goldstein DP, King EV, de Almeida JR, Brown DH, Gilbert RW, Gullane PJ, Espin-Garcia O, Xu W, Irish JC. Correlation between clinical and MRI assessment of depth of invasion in oral tongue squamous cell carcinoma. J Otolaryngol Head Neck Surg. 2016 Nov 22;45(1):61. doi: 10.1186/s40463-016-0172-0.

  PMID: 27876067 BACKGROUND

• 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: 29362123 BACKGROUND

• Nilsson O, Knutsson J, Landstrom FJ, Magnuson A, von Beckerath M. Ultrasound-assisted resection of oral tongue cancer. Acta Otolaryngol. 2022 Sep-Dec;142(9-12):743-748. doi: 10.1080/00016489.2022.2153916. Epub 2022 Dec 20.

  PMID: 36537851 DERIVED

MeSH Terms

Conditions

Tongue Neoplasms; Margins of Excision

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Johan Knutsson, Assoc. Prof.

  Region Örebro County

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The ultrasound examiner should not be aware of the results of the MRI.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trial

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 16, 2019
• Study Start: May 28, 2019
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: December 27, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication.
• Access Criteria: Coded, computerized IPD will be available upon a request with the serious intention to improve the scientific knowledge and transparency.

Locations

SE (1)