Ex Vivo 3D-ultrasound for Oropharyngeal Cancer

Rigshospitalet

Status: Completed

Conditions: Oropharyngeal Squamous Cell Carcinoma

Treatments: Diagnostic Test: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06314711

Ex Vivo US for OPC

Details and patient eligibility

About

Patients with biopsy-verified oropharyngeal squamous cell carcinomas treated with transoral robotic surgery are included. Immediately post-operatively, freshly resected specimens are examined with ex vivo 3D ultrasound (US).

Ex vivo 3D US will be used to match US slices of the specimen with corresponding histopathology slices. The US slices will be reviewed by a panel of head and neck surgeons blinded to histopathology.

The primary aim is to explore perioperative ex vivo 3D US for oropharyngeal tumor detection, delineation from normal tissue, tumor size and volume, and margin assessment.

Full description

The purpose of the study is to determine the accuracy of ex vivo 3D ultrasound (US) for detecting and delineating tumor tissue of the tonsils and base of tongue post-operatively. This is a quick technique that may provide valuable information for the surgeon that can potentially improve treatment outcomes.

Placing the surgical specimen in a water bath allows for an US swipe to be performed without compressing the specimen. This reduces the deformation of the specimen by removing the pressure from conventional US scanning. A video clip can be captured by swiping across the specimen in the water bath. By motorizing this motion, the video can be converted into a 3D volume due to the known number of video frames and a constant swiping speed.

We will correlate the ex vivo 3D US scans to histopathology for the following analyses:

• Four surgeons blinded to histopathology will rate each included case in terms of tumor visibility on ex vivo 3D US scans. If visible, the surgeons will mark the tumor and the healthy tissue.
• Tumor and margins will be correlated to histopathology pre- and post-formalin fixation on a subset of cases to explore the proportion of tissue shrinkage from formalin fixation.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients surgically treated with transoral robotic surgery for oropharyngeal squamous cell carcinoma.

Exclusion criteria

• Patients from the QOLATI trial (NCT04124198)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Post-operative ex vivo 3D ultrasound

Experimental group

Description:

3D ultrasound of surgical specimen

Treatment:

Diagnostic Test: Ultrasound