Intervention: Diagnostic Test: PET/MRI
Sponsors: Odense University Hospital; University of Southern Denmark
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The Diagnostic Value of PET/MRI in Head and Neck Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04117139
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 8, 2019
See Contacts and Locations
Sponsor:
Odense University Hospital
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Chadi Nimeh Abdel-Halim, Odense University Hospital
Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
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Brief Summary:
This study investigates the diagnostic value of PET/MRI for cervical lymph node metastases from head and neck squamous cell carcinomas.
Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Head and Neck
Head and Neck Neoplasms
Lymph Node Metastases
Diagnostic Test: PET/MRI
Not Applicable
Detailed Description:
The Danish fast-track cancer program standardizes the work-up of patients suspected of head and neck cancer. Currently, the guidelines recommend head and neck magnetic resonance imaging (MRI) as the standard imaging modality for assessment of the primary tumor site and potential nodal metastases. However, recent studies have shown advantages in the use of 18F-FDG-PET (PET) combined with computed tomography (CT) due to its superiority in detecting metastases and synchronous cancers.
During the last couple of years PET/MRI has been introduced. MRI is known to provide the highest anatomic detail in the head and neck region, and preliminary studies show promising results. However, the evidence is still very sparse.
The purpose of the project is to investigate the diagnostic value of PET/MRI in patients with head and neck squamous cell carcinoma. The hypothesis is that PET/MRI provides a more precise diagnosis of regional lymph node metastases, and thus, make the surgical treatment of the neck more accurate and less invasive resulting in reduced morbidity.
The project is designed as a prospective cohort study based on paired data with head-to-head comparison of CT, MRI, PET/CT and PET/MRI. Patients will be included from the head and neck cancer fast-track program at the Center of Head and Neck Cancer, Odense University Hospital (OUH).
Included patients will be offered PET/MRI in addition to the conventional fast-track imaging. The description of the images will be made blinded. When a neck dissection of the lymph nodes is made, the lymph nodes will be separated in defined regions. The diagnostic accuracy of the individual imaging modalities is assessed for each neck level with histology as standard reference.
Study Design
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Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 142 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics: Head and neck squamous cell carcinoma
MedlinePlus related topics: MRI Scans
U.S. FDA Resources
Arms and Interventions
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Arm Intervention/treatment
Study Group
In addition to other standard imaging modalities in the fast track cancer program, included patients will have a PET/MRI done.
Diagnostic Test: PET/MRI
A PET/MRI of the Head and Neck region is done for all patients included in the project.
Other Names:
18F-FDG-PET/MRI
FDG-PET/MRI
PET/MR
PET-MR
Positron-Emission-Tomography/Magnetic Resonance Imaging
Outcome Measures
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Primary Outcome Measures :
Diagnostic Accuracy of PET/MRI for Malignancy in Regional Lymph Nodes [ Time Frame: 7-10 days ]
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
Secondary Outcome Measures :
Diagnostic Accuracy of PET/MRI for Extracapsular Lymph Node Spread [ Time Frame: 7-10 days ]
PET/MRI scans are compared to histology as the golden standard to determine the diagnostic accuracy of PET/MRI for extracapsular spread in regional lymph nodes
Eligibility Criteria
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Contacts and Locations
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117139
Contacts
Contact: Christian Godballe, Professor +45 6541 2800 christian.godballe@rsyd.dk
Contact: Chadi N. Abdel-Halim, M.D. chadi.nimeh.abdel-halim3@rsyd.dk
Locations
Denmark
Department of ORL - Head & Neck Surgery and Audiology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Chadi N. Abdel-Halim, M.D.
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Investigators
Principal Investigator: Chadi N. Abdel-Halim, M.D. Odense University Hospital
More Information
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Additional Information:
Description of the PET/MRI facilities at Odense University Hospital This link exits the ClinicalTrials.gov site
Responsible Party: Chadi Nimeh Abdel-Halim, Medical Doctor and Principal Investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT04117139 History of Changes
Other Study ID Numbers: HNC PET/MRI
First Posted: October 7, 2019 Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chadi Nimeh Abdel-Halim, Odense University Hospital:
Positron-Emission-Tomography/Magnetic Resonance Imaging
PET/MRI
Cancer staging
Additional relevant MeSH terms:
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Carcinoma, Squamous Cell
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
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