AzTrials
AzTrials

Squamous Cell CarcinomaNCT05843032

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

A study testing 3D ultrasound, MRI, resected specimen examination by surgeon in people with Squamous Cell Carcinoma and Tongue SCC, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
3D ultrasound, MRI, resected specimen examination by surgeon
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteDenmark
Study dates
15 May 2023to 15 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Fatemeh Makouei, PhD contact

+4550243760

fatemeh.makouei@regionh.dk

Tobias Todsen, MD, PhD contact

+4535452071

tobias.todsen@regionh.dk

Denmark1 site

  • Rigshospitalet

    Copenhagen, Capital Region, 2100

    Tobias Todsen, MD, PhD, +4535452071, tobias.todsen@regionh.dk

Other trials in Denmark

About this study

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

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.

Read the detailed 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.

Being tested
3D ultrasound, MRI, resected specimen examination by surgeon
Keywords
Ultrasound, 3D ultrasound, Ultrasonography, Three dimensional imaging, cancer diagnosis, surgical margin assessment, magnetic resonance imaging, MRI, ex-vivo surgical specimen imaging, squamous cell carcinoma, histopathology, SCC, oral cancer
Medical subject headings
Carcinoma, Squamous Cell, Head and Neck Neoplasms, Mouth Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D ultrasound, MRI, resected specimen examination by surgeonDiagnostic test

    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.

Study groups in NCT05843032
Study groupRoleWhat they receive
Tongue tumor resectionExperimentalNot described
Receives: Diagnostic Test: 3D ultrasound, MRI, resected specimen examination by surgeon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of the 3D ultrasound and MRI compared to the conventional method in measurements of the surgical margins in the resected tongue SCC specimens.

    Measured: 2 weeks

  2. 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

    Measured: 2 weeks

Secondary outcomes (2)

  1. Number of cases requiring adjuvant treatments (surgery or chemo/radiotherapy)

    Measured: 2 weeks

  2. Shrinkage of the surgical specimen due to formalin fixation based on the specimen volume measurements on 3D ultrasound images before and after formalin fixation

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start15 May 2023 (estimated)
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion15 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05843032
Sponsor's protocol ID
21017915
Status last verified
May 2023
First submitted
24 Apr 2023
Last updated
9 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 26351335

  • 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.

    PubMed 33030524

  • 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.

    PubMed 31695503

  • 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.

    PubMed 33774501

  • 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.

    PubMed 8745780

  • 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.

    PubMed 29362123

  • 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.

    PubMed 30151976

  • 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.

    PubMed 35901543

  • 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.

    PubMed 36547494

Questions about this trial

What is this clinical trial studying?

A study testing 3D ultrasound, MRI, resected specimen examination by surgeon in people with Squamous Cell Carcinoma and Tongue SCC, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fatemeh Makouei, PhD (+4550243760, fatemeh.makouei@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of the 3D ultrasound and MRI compared to the conventional method in measurements of the surgical margins in the resected tongue SCC specimens. (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05843032, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in