Ex Vivo 3D-ultrasound for Oropharyngeal Cancer

Not Applicable

Completed

• Conditions: Oropharyngeal Squamous Cell Carcinoma

• Registration Number: NCT06314711
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Patients with biopsy-verified oropharyngeal squamous cell carcinoma or Human Papillomavirus (HPV)-positive unknown primary 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.

Detailed 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.

* Two methods of estimating tumor volume will be compared: the ellipsoidal formula and full 3D segmentation.

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients surgically treated with transoral robotic surgery for oropharyngeal squamous cell carcinoma or HPV-positive unknown primary.

Exclusion Criteria

• No primary tumor found on final histopathology.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Blind-assessed tumor size from fresh ex vivo US	day 1	Tumor width and thickness (mm) estimated by blinded perioperative ex vivo 3D-US
Blind-assessed deep and lateral margin measurements on fresh ex vivo US	day 1	Deep and lateral margin measurements (mm) by blinded perioperative ex vivo 3D-US.

Secondary Outcome Measures

Name	Time	Method
Fresh vs formalin-fixed ex vivo US tumor volume	day 1	Comparison of tumor volumes (mm\^3) estimated by ex vivo perioperative 3D-US before and after formalin fixation.
Margin involvement (categorical)	day 1	Blinded evaluation of involved tumor margins (involved vs not involved)

Trial Locations

Locations (1)

Dept. of Otorhinolaryngology, Head & Neck Surg, Rigshospitalet; 🇩🇰 Copenhagen, Denmark