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

October 4, 2019 updated by: Chadi Nimeh Abdel-Halim, Odense University Hospital

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

This study investigates the diagnostic value of PET/MRI for cervical lymph node metastases from head and neck squamous cell carcinomas.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Recruiting
        • Department of ORL - Head & Neck Surgery and Audiology, Odense University Hospital
        • Contact:
          • Chadi N. Abdel-Halim, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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:
  • PET-MR
  • 18F-FDG-PET/MRI
  • FDG-PET/MRI
  • PET/MR
  • Positron-Emission-Tomography/Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7-10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7-10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

University of Southern Denmark

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (Actual)

October 7, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2019

Last Update Submitted That Met QC Criteria

October 4, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNC PET/MRI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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