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

Primary Purpose

Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Lymph Node Metastases

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PET/MRI
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Squamous Cell Carcinoma of Head and Neck focused on measuring Positron-Emission-Tomography/Magnetic Resonance Imaging, PET/MRI, Cancer staging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of ORL - Head & Neck Surgery and Audiology, Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Group

Arm Description

In addition to other standard imaging modalities in the fast track cancer program, included patients will have a PET/MRI done.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Diagnostic Accuracy of PET/MRI for Extracapsular Lymph Node Spread
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

Full Information

First Posted
October 3, 2019
Last Updated
October 4, 2019
Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04117139
Brief Title
The Diagnostic Value of PET/MRI in Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Lymph Node Metastases
Keywords
Positron-Emission-Tomography/Magnetic Resonance Imaging, PET/MRI, Cancer staging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Other
Arm Description
In addition to other standard imaging modalities in the fast track cancer program, included patients will have a PET/MRI done.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/MRI
Other Intervention Name(s)
18F-FDG-PET/MRI, FDG-PET/MRI, PET/MR, PET-MR, Positron-Emission-Tomography/Magnetic Resonance Imaging
Intervention Description
A PET/MRI of the Head and Neck region is done for all patients included in the project.
Primary Outcome Measure Information:
Title
Diagnostic Accuracy of PET/MRI for Malignancy in Regional Lymph Nodes
Description
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
Time Frame
7-10 days
Secondary Outcome Measure Information:
Title
Diagnostic Accuracy of PET/MRI for Extracapsular Lymph Node Spread
Description
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
Time Frame
7-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Godballe, Professor
Phone
+45 6541 2800
Email
christian.godballe@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Chadi N. Abdel-Halim, M.D.
Email
chadi.nimeh.abdel-halim3@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chadi N. Abdel-Halim, M.D.
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of ORL - Head & Neck Surgery and Audiology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chadi N. Abdel-Halim, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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