Τετάρτη 9 Οκτωβρίου 2019

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

The Diagnostic Value of PET/MRI in Head and Neck Cancer: Conditions:   Squamous Cell Carcinoma of Head and Neck;   Head and Neck Neoplasms;   Lymph Node Metastases

Intervention:   Diagnostic Test: PET/MRI

Sponsors:   Odense University Hospital;   University of Southern Denmark

Recruiting



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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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