Clinical Trials Logo
  1. Home
  2. Head and Neck Cancer
  3. NCT05740774
  4. Details
NCT05740774 Clinical Trial

Surgical Margin Assessment by 3D Ultrasound

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05740774
Other study ID # 21017915a
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date April 30, 2023

Study information
Verified date February 2023
Source Rigshospitalet, Denmark
Contact Fatemeh Makouei
Phone 50243760
Email fatemeh.makouei@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 7
Est. completion date April 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 3D ultrasound
3D ultrasound scanning of the resected tongue tumor will be performed. The margin analysis will be made using the 3D ultrasound image.

Locations
Country Name City State
Denmark Rigshospitalet København Ø Dk-015

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (8)

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. — View 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. — View 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. — 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

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. — View 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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 2 weeks
Primary Diagnostic accuracy number of margins correctly classified as free (> 5 mm), close (< 5 mm) or positive (<1 mm) margin 2 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05808920 - The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03997643 - Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04700475 - Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients. N/A
Withdrawn NCT04058145 - AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT02572869 - Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
Active, not recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Withdrawn NCT05073809 - Photoacoustic Imaging of Head and Neck Tumours
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT03651570 - Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study N/A
Recruiting NCT04930432 - Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors Phase 1/Phase 2
Recruiting NCT06016699 - Immunological Function After Radiation With Either Proton or Photon Therapy
Terminated NCT03843554 - Commensal Oral Microbiota in Head and Neck Cancer N/A
Recruiting NCT05915572 - Mulligan Technique on Shoulder Dysfunction N/A
Completed NCT05897983 - Tens and Rocabado Exercises on TMJ Dysfunction N/A
Not yet recruiting NCT06289049 - Heavy Strength Training in Head and Neck Cancer Survivors Phase 2
Withdrawn NCT05263648 - Virtual Reality Software to Reduce Stress in Cancer Patients N/A
Withdrawn NCT03238638 - A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy Phase 2