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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedFirst Submitted
Initial submission to the registry
March 6, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedSeptember 19, 2024
May 1, 2024
2.3 years
March 6, 2024
September 9, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Blind-assessed tumor size from fresh ex vivo US
Tumor width and thickness (mm) estimated by blinded perioperative ex vivo 3D-US
day 1
Blind-assessed deep and lateral margin measurements on fresh ex vivo US
Deep and lateral margin measurements (mm) by blinded perioperative ex vivo 3D-US.
day 1
Secondary Outcomes (2)
Fresh vs formalin-fixed ex vivo US tumor volume
day 1
Margin involvement (categorical)
day 1
Study Arms (1)
Post-operative ex vivo 3D ultrasound
EXPERIMENTAL3D ultrasound of surgical specimen
Interventions
High-frequency ultrasound of ex vivo specimen
Eligibility Criteria
You may qualify if:
- Patients surgically treated with transoral robotic surgery for oropharyngeal squamous cell carcinoma.
You may not qualify if:
- Patients from the QOLATI trial (NCT04124198)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Otorhinolaryngology, Head & Neck Surg, Rigshospitalet
Copenhagen, 2100, Denmark
Related 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.
PMID: 37754938BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 6, 2024
First Posted
March 18, 2024
Study Start
October 1, 2021
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
September 19, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share