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Surgical Margin Assessment by 3D Ultrasound

Primary Purpose

Tongue Cancer, Squamous Cell Carcinoma, Head and Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
3D ultrasound
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tongue Cancer focused on measuring 3D ultrasound, Histopathology, Ultrasonography, Three dimensional imaging, cancer diagnosis, tongue tumor

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-T2 staging on cross-sectional imaging Exclusion Criteria: Age < 18 yrs T3-T4 staging Unable to understand the verbal or written information Prior radiotherapy treatment of oral cavity cancer

Sites / Locations

  • RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tongue tumor resection

Arm Description

Outcomes

Primary Outcome Measures

Correlation of the surgical margin measurements of the 3D ultrasound to histopathology
The smallest margin will be measured in mm on 3D ultrasound image of the ex-vivo surgical specimen. Correlation of the measurement to the final histopathology result will be investigated.
Diagnostic accuracy
number of margins correctly classified as free (> 5 mm), close (< 5 mm) or positive (<1 mm) margin

Secondary Outcome Measures

Full Information

First Posted
February 11, 2023
Last Updated
February 22, 2023
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05740774
Brief Title
Surgical Margin Assessment by 3D Ultrasound
Official Title
Feasibility of 3D Ultrasound in the Assessment of Resection Margins During Surgery for Squamous Cell Carcinoma of the Tongue: a Comparison With Histopathology
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (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
Complete removal of cancer encircled by a secure margin of healthy tissue is the aim of surgical oncology. A close or positive surgical margin reported by pathologist typically ends in adjuvant therapies (re-surgery and/or radiotherapy), which come with prognostic risks and financial cost. Therefore, ex-vivo imaging of removed cancer tissue may assist in margin evaluation. In this study, investigators aimed to investigate the correlation of 3D ultrasound to histopathology to assess tongue tumor margin status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tongue Cancer, Squamous Cell Carcinoma, Head and Neck Cancer
Keywords
3D ultrasound, Histopathology, Ultrasonography, Three dimensional imaging, cancer diagnosis, tongue tumor

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Tongue tumor resection
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
3D ultrasound
Intervention Description
3D ultrasound scanning of the resected tongue tumor will be performed. The margin analysis will be made using the 3D ultrasound image.
Primary Outcome Measure Information:
Title
Correlation of the surgical margin measurements of the 3D ultrasound to histopathology
Description
The smallest margin will be measured in mm on 3D ultrasound image of the ex-vivo surgical specimen. Correlation of the measurement to the final histopathology result will be investigated.
Time Frame
2 weeks
Title
Diagnostic accuracy
Description
number of margins correctly classified as free (> 5 mm), close (< 5 mm) or positive (<1 mm) margin
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-T2 staging on cross-sectional imaging Exclusion Criteria: Age < 18 yrs T3-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
Phone
50243760
Email
fatemeh.makouei@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Todsen
Phone
35456008
Email
tobias.todsen@regionh.dk
Facility Information:
Facility Name
Rigshospitalet
City
København Ø
State/Province
Dk-015
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Todsen, MD, PhD
Phone
35456008
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
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
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
background
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
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
background
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
background
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
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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Surgical Margin Assessment by 3D Ultrasound

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