Ex Vivo 3D-ultrasound for Oropharyngeal Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Oropharyngeal Squamous Cell Carcinoma
• Intervention / Treatment: Diagnostic test: Ultrasound

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Dept. of Otorhinolaryngology, Head & Neck Surg, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post-operative ex vivo 3D ultrasound; 3D ultrasound of surgical specimen	Diagnostic test: Ultrasound; High-frequency ultrasound of ex vivo specimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fresh ex vivo US Tumor detection (blinded to histopathology)	Whether the tumor is visible on US (binary yes/no and 5-point scale from 1: very low certainty - 5 very high certainty)	5 minutes
Margin assessment (blinded to histopathology)	Whether the tumor is removed with negative margins (yes / no)	5 minutes
Fresh ex vivo US tumor volume (blinded to histopathology)	Measured with ellipsoid volume (mm^3)	5 minutes
Fresh ex vivo US margin distance (blinded to histopathology)	Smallest and mean margins measured in mm.	5 minutes
Fresh ex vivo tumor visible on specimen mecrophoto (blinded to histopathology)	Whether the tumor is visible clinically by inspecting the macrophoto.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fresh ex vivo US tumor volume (unblinded to histopathology)	Measured with ellipsoid volume and segmentation (mm^3)	1 day
Formalin-fixed ex vivo US tumor volume (unblinded to histopathology)	Measured with ellipsoid volume and segmentation (mm^3)	1 day
Fresh ex vivo US margin distance (unblinded to histopathology)	Smallest and mean margins measured in mm.	1 day
Formalin-fixed ex vivo US margin distance (unblinded to histopathology)	Smallest and mean margins measured in mm.	1 day

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Publications and helpful links

General Publications

• Makouei F, Agander TK, Ewertsen C, Sondergaard Svendsen MB, Norling R, Kaltoft M, Hansen AE, Rasmussen JH, Wessel I, Todsen T. 3D Ultrasound and MRI in Assessing Resection Margins during Tongue Cancer Surgery: A Research Protocol for a Clinical Diagnostic Accuracy Study. J Imaging. 2023 Aug 28;9(9):174. doi: 10.3390/jimaging9090174.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: Ex Vivo US for OPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No