Surgical Margin Assessment by 3D Ultrasound

Rigshospitalet

Status: Enrolling

Conditions: Squamous Cell Carcinoma; Head and Neck Cancer; Tongue Cancer

Treatments: Diagnostic Test: 3D ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT05740774

21017915a

Details and patient eligibility

About

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.

Enrollment: 7 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Tongue tumor resection

Experimental group

Treatment:

Diagnostic Test: 3D ultrasound