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

Tongue Cancer Clinical Trial

Official title:

Ultrasound in Oral Tongue Cancer- Measurement of Depth of Invasion and Intraoperative Help in the Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059861
• Other study ID #: 252891
• Status: Completed
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: November 29, 2021

Study information

• Verified date: March 2021
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The first part of this study will try to answer if ultrasound can improve the preoperative measurement of depth of invasion in tongue cancer and floor of the mouth cancer. The study population is new patients meeting the eligibility criteria presented to the hospital for treatment. Participants will be enrolled only after accepting the oral and written information and signing the written consent paper.

The examiner, one of three otorhinolaryngologists experienced in ultrasound, should be masked to the results of MRI. The first measurement is depth of invasion as well as thickness of the tumour in mm by palpation on awake patient. Thereafter the same measurements by ultrasound (BK Medical Medical flex focus 500, 18Mhz) with gel and protective cover is made with 0,5mm accuracy. Anesthetic gel or lingual block with carbocaine/adrenaline are provided as needed.

At the time of surgery the measurements above are done again on the patient in narcosis before the resection.

Images of the ultrasound measurements are saved for documentation. The results are compared to the corresponding measurements on MRI and also on PAD from the surgical specimen. PAD is considered gold standard.

Power calculation with help of biostatistician yielded a sample size of 55 patients, using a paired test with a 0,050 one-sided significance level will have 80% power to reject the null hypothesis that the proportions are not equivalent.

Analysis if ultrasound correctly classify the tumour´s DOI according to the TNM-classification 8th edition (<5mm, >5mm<10mm, >10mm) will be made.

The second part of the study will investigate if ultrasound during the surgical procedure can improve the discrimination of the deep margin of the tumour and thereby increasing the chance better surgical margins. The mucosal margins are marked in the usual fashion and the resection begins. After one fourth of the resection has been made, ultrasound is used to check that the deep margin is at least 10mm. This is repeated after one half and three quarters of the resection. At the end of the surgery a final ultrasound examination is made on the surgical specimen.

The margins obtained on PAD from resections done with ultrasound are compared to a matched retrospective group where the surgery was done without ultrasound.

After inclusion started our group started cooperation with another biostatician whom judged the analysis better be done from the quantitative variable of DOI in millimeter. This meant the power analysis shifted and a study population of between 15-23 participants was considered sufficient. Since the original plan was 55 participants we kept that number but after an interim analysis in may 2021 a total of 42 participants is now what we consider relevant in the study of DOI.

In our second endpoint studying ultrasound and surgical margin the interim analysis concluded that collection of patients for 2 years (may 2019 until may 2021) will be compared to a historical control group 4 years back in time (may 2015 until may 2019) and therefore the inclusion of that data stopped in may 2019.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 29, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Floor of Mouth Squamous Cell Carcinoma
• Tongue Cancer
• Tongue Neoplasms

Intervention

Diagnostic Test:
• Ultrasound
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.

Locations

Country	Name	City	State
Sweden	Örebro University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — 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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depth of invasion	Depth of invasion in millimeters measured by ultrasound compared to Clinical palpation , MRI and PAD.	up to 6 weeks.
Primary	Intraoperative ultrasound helpful during surgery	Comparison of surgical margins in resections done with and without the assistance of ultrasound.	up to 6 weeks.