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Completed

NCT Number: NCT06314711

Ex Vivo 3D-ultrasound for Oropharyngeal Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Otorhinolaryngology, Head & Neck Surg, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients from the QOLATI trial (NCT04124198)

Treatment and study plan

Ultrasound

Diagnostic Test

High-frequency ultrasound of ex vivo specimen

Primary outcomes

  1. Blind-assessed tumor size from fresh ex vivo US

    Time frame: day 1

    Tumor width and thickness (mm) estimated by blinded perioperative ex vivo 3D-US

  2. Blind-assessed deep and lateral margin measurements on fresh ex vivo US

    Time frame: day 1

    Deep and lateral margin measurements (mm) by blinded perioperative ex vivo 3D-US.

Secondary outcomes

  1. Fresh vs formalin-fixed ex vivo US tumor volume

    Time frame: day 1

    Comparison of tumor volumes (mm^3) estimated by ex vivo perioperative 3D-US before and after formalin fixation.

  2. Margin involvement (categorical)

    Time frame: day 1

    Blinded evaluation of involved tumor margins (involved vs not involved)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Tumor Volume and Margin Assessment with Ex Vivo 3D-ultrasound After Transoral Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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