The Diagnostic Value of PET/MRI in Head and Neck Cancer
The Diagnostic Value of 18F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose-Positron-Emission-Tomography/Magnetic-Resonance Imaging (PET/MRI) for Cervical Lymph Node Metastasis in Head and Neck Squamous Cell Carcinoma
1 other identifier
interventional
142
1 country
1
Brief Summary
This study investigates the diagnostic value of PET/MRI for cervical lymph node metastases from head and neck squamous cell carcinomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 3, 2019
CompletedFirst Posted
Study publicly available on registry
October 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedOctober 8, 2019
October 1, 2019
2 years
October 3, 2019
October 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic Accuracy of PET/MRI for Malignancy in Regional Lymph Nodes
PET/MRI scans are compared to histology as the golden standard to determine the diagnostic accuracy of PET/MRI for malignancy in regional lymph nodes
7-10 days
Secondary Outcomes (1)
Diagnostic Accuracy of PET/MRI for Extracapsular Lymph Node Spread
7-10 days
Study Arms (1)
Study Group
OTHERIn addition to other standard imaging modalities in the fast track cancer program, included patients will have a PET/MRI done.
Interventions
A PET/MRI of the Head and Neck region is done for all patients included in the project.
Eligibility Criteria
You may qualify if:
- Patients either suspected of or with histologically verified:
- Relapse of head and neck squamous cell cancer with involvement of regional lymph node(s)
- Cervical lymph node metastasis with unknown primary tumor site
- Oral cavity squamous cell carcinoma
- Oropharyngeal squamous cell cancer planned for trans oral robotic surgery
You may not qualify if:
- Patients who cannot have a PET/MRI performed for different reasons (allergy, claustrophobia, medical implants)
- Patients who had surgery, infection or other inflammatory inducing conditions on the neck within the last 8 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- University of Southern Denmarkcollaborator
Study Sites (1)
Department of ORL - Head & Neck Surgery and Audiology, Odense University Hospital
Odense, 5000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chadi N. Abdel-Halim, M.D.
Odense University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor and Principal Investigator
Study Record Dates
First Submitted
October 3, 2019
First Posted
October 7, 2019
Study Start
October 1, 2019
Primary Completion
September 30, 2021
Study Completion
September 30, 2022
Last Updated
October 8, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share