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The Diagnostic Value of PET/MRI in Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT04117139
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Chadi Nimeh Abdel-Halim, Odense University Hospital

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.


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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

MedlinePlus related topics: MRI Scans

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




Primary Outcome Measures :
  1. 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 :
  1. 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



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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

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
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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
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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
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Principal Investigator: Chadi N. Abdel-Halim, M.D. Odense University Hospital

Additional Information:
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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

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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:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasm Metastasis
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplastic Processes
Pathologic Processes
Neoplasms by Site