Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2021-10-01
2024-02-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Post-operative ex vivo 3D ultrasound
3D ultrasound of surgical specimen
Ultrasound
High-frequency ultrasound of ex vivo specimen
Interventions
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Ultrasound
High-frequency ultrasound of ex vivo specimen
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Martin Garset-Zamani, MD
Principal Investigator
Locations
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Dept. of Otorhinolaryngology, Head & Neck Surg, Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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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.
Other Identifiers
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Ex Vivo US for OPC
Identifier Type: -
Identifier Source: org_study_id
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