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

Primary Purpose

Squamous Cell Carcinoma, Tongue SCC, Head and Neck Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
3D ultrasound, MRI, resected specimen examination by surgeon
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Squamous Cell Carcinoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with biopsy-proven oral tongue squamous cell carcinoma scheduled for surgical treatment T1-T3 staging on cross-sectional imaging Exclusion Criteria: T4 staging Unable to understand the verbal or written information Prior radiotherapy treatment of oral cavity cancer

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tongue tumor resection

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of cases requiring adjuvant treatments (surgery or chemo/radiotherapy)
Shrinkage of the surgical specimen due to formalin fixation based on the specimen volume measurements on 3D ultrasound images before and after formalin fixation

Full Information

First Posted
April 24, 2023
Last Updated
May 5, 2023
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05843032
Brief Title
3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma, Tongue SCC, Head and Neck Cancer
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tongue tumor resection
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
3D ultrasound, MRI, resected specimen examination by surgeon
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Number of cases requiring adjuvant treatments (surgery or chemo/radiotherapy)
Time Frame
2 weeks
Title
Shrinkage of the surgical specimen due to formalin fixation based on the specimen volume measurements on 3D ultrasound images before and after formalin fixation
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with biopsy-proven oral tongue squamous cell carcinoma scheduled for surgical treatment T1-T3 staging on cross-sectional imaging Exclusion Criteria: T4 staging Unable to understand the verbal or written information Prior radiotherapy treatment of oral cavity cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatemeh Makouei, PhD
Phone
+4550243760
Email
fatemeh.makouei@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Todsen, MD, PhD
Phone
+4535452071
Email
tobias.todsen@regionh.dk
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Todsen, MD, PhD
Phone
+4535452071
Email
tobias.todsen@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Available for 5 years
Citations:
PubMed Identifier
26351335
Citation
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.
Results Reference
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PubMed Identifier
33030524
Citation
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.
Results Reference
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PubMed Identifier
31695503
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.
Results Reference
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PubMed Identifier
33774501
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.
Results Reference
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PubMed Identifier
8745780
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.
Results Reference
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PubMed Identifier
29362123
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.
Results Reference
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PubMed Identifier
30151976
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.
Results Reference
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PubMed Identifier
35901543
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.
Results Reference
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PubMed Identifier
36547494
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.
Results Reference
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3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment

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