Ex Vivo 3D-ultrasound for Oropharyngeal Cancer

Oropharyngeal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06314711
• Other study ID #: Ex Vivo US for OPC
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oropharyngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Diagnostic Test:
• Ultrasound
High-frequency ultrasound of ex vivo specimen

Locations

Country	Name	City	State
Denmark	Dept. of Otorhinolaryngology, Head & Neck Surg, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Margin assessment (blinded to histopathology)	Whether the tumor is removed with negative margins (yes / no)	5 minutes
Primary	Fresh ex vivo US tumor volume (blinded to histopathology)	Measured with ellipsoid volume (mm^3)	5 minutes
Primary	Fresh ex vivo US margin distance (blinded to histopathology)	Smallest and mean margins measured in mm.	5 minutes
Primary	Fresh ex vivo tumor visible on specimen mecrophoto (blinded to histopathology)	Whether the tumor is visible clinically by inspecting the macrophoto.	5 minutes
Secondary	Fresh ex vivo US tumor volume (unblinded to histopathology)	Measured with ellipsoid volume and segmentation (mm^3)	1 day
Secondary	Formalin-fixed ex vivo US tumor volume (unblinded to histopathology)	Measured with ellipsoid volume and segmentation (mm^3)	1 day
Secondary	Fresh ex vivo US margin distance (unblinded to histopathology)	Smallest and mean margins measured in mm.	1 day
Secondary	Formalin-fixed ex vivo US margin distance (unblinded to histopathology)	Smallest and mean margins measured in mm.	1 day