Clinical trial · Interventional
Ultrasound in Tongue Cancer- a Help to Decide Depth of Invasion and to Improve the Surgical Margin
Ultrasound in Oral Tongue Cancer- Measurement of Depth of Invasion and Intraoperative Help in the Resection
NCT04059861CI-TRIAL-00055673completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Floor of Mouth Squamous Cell Carcinoma | Floor of Mouth Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Tongue Cancer | Malignant Tongue Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ultrasound assisted resection
- description
- resection of tongue cancer will be done with assistance of ultrasound to visualise the deep margin.
- interventionNames
- Diagnostic Test: Ultrasound
Primary outcomes (2)
- measure
- Depth of invasion
- timeFrame
- up to 6 weeks.
- description
- Depth of invasion in millimeters measured by ultrasound compared to Clinical palpation , MRI and PAD.
- measure
- Intraoperative ultrasound helpful during surgery
- timeFrame
- up to 6 weeks.
- description
- Comparison of surgical margins in resections done with and without the assistance of ultrasound.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDBaek 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
- BACKGROUNDKodama 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
- BACKGROUNDTarabichi 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
- BACKGROUNDLydiatt 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
- BACKGROUNDInternational 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
- BACKGROUNDLam 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.