Tongue Cancer, Squamous Cell Carcinoma, Head and Neck Cancer
Conditions
Keywords
3D ultrasound, Histopathology, Ultrasonography, Three dimensional imaging, cancer diagnosis, tongue tumor
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.
Interventions
DIAGNOSTIC_TEST3D ultrasound
3D ultrasound scanning of the resected tongue tumor will be performed. The margin analysis will be made using the 3D ultrasound image.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of the surgical margin measurements of the 3D ultrasound to histopathology | 2 weeks | 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 | 2 weeks | number of margins correctly classified as free (\> 5 mm), close (\< 5 mm) or positive (\<1 mm) margin |
Countries
Denmark
Contacts
Primary ContactFatemeh Makouei
Backup ContactTobias Todsen
Outcome results
None listed