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Trial Title:
Surgical Margin Assessment by 3D Ultrasound
NCT ID:
NCT05740774
Condition:
Tongue Cancer
Squamous Cell Carcinoma
Head and Neck Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Tongue Neoplasms
Conditions: Keywords:
3D ultrasound
Histopathology
Ultrasonography
Three dimensional imaging
cancer diagnosis
tongue tumor
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
3D ultrasound
Description:
3D ultrasound scanning of the resected tongue tumor will be performed. The margin
analysis will be made using the 3D ultrasound image.
Arm group label:
Tongue tumor resection
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Rigshospitalet
Address:
City:
København Ø
Zip:
2100
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Tobias Todsen, MD, PhD
Phone:
35456008
Email:
tobias.todsen@regionh.dk
Start date:
January 1, 2023
Completion date:
April 30, 2023
Lead sponsor:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Source:
Rigshospitalet, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05740774
