Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314711
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2024-03-06
Brief Title:
Ex Vivo 3D-ultrasound for Oropharyngeal Cancer
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Tumor Volume and Margin Assessment with Ex Vivo 3D-ultrasound After Transoral Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None