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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06314711
Enrollment
15
Registered
2024-03-18
Start date
2021-10-01
Completion date
2024-02-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Squamous Cell Carcinoma

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTUltrasound

High-frequency ultrasound of ex vivo specimen

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patients from the QOLATI trial (NCT04124198)

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026