Role of PET/MRI in Head and Neck Cancer

December 24, 2020 updated by: Omar Freihat, University of Pecs

PET/CT and PET/MRI Based Treatment Modalities in the Modern Oncology

Study aim was to investigate the diagnostic role of Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) in head and neck cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was assessed the role of Diffusion weighted imaging (DWI) in discriminating between benign and malignant lesions in Head and neck cancer as well as studying the relationship between glucose metabolism (18F-FDG) and Apparent diffusion coefficient (ADC) for better tumor assessment.

Study Type

Observational

Enrollment (Actual)

110

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

41 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population were patients who have been diagnosed with head and neck cancer.

Description

Inclusion Criteria:

  • Proved Head and neck cancer
  • Underwent PET/CT and PET/MRI
  • Lymph nodes due to primary Head and neck cancer.

For healthy subject:

  • No previous history of malignancy.
  • no inflammation or infection in the neck region.
  • lymph node size <10mm.

Exclusion Criteria:

  • patients treated before by radiotherapy / chemoradiotherapy
  • patients underwent surgery
  • artifacts

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients underwent PET/CT & PET/MRI
Patients with head and neck cancer were underwent PET/CT and PET/MRI for staging, assessment and follow up
Radiation: Radiotherapy
Patients have received radiotherapy as a treatment modality for Head and neck cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Apparent diffusion coefficient value between benign and malignant lesions
Time Frame: Baseline
Apparent diffusion coefficient (ADC) was measured from benign and malignant lymph nodes by drawing region of interest (ROI) on the most homogeneous and most solid part in the target lymph node. Higher ADC value in Benign lymph node means that there are more water molecules movement inside the lymph node, more water molecules movement resulting in higher Apparent diffusion coefficient value. in malignant nodes and due to more tumor tissue, the result is to have lower water molecules motion so, lower ADC value.
Baseline

Collaborators and Investigators

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

Sponsor

University of Pecs

Investigators

  • Study Director: Arpad Kovacs, MD, PhD, University of Pecs
  • Study Chair: Cselik Zsolt, MD, PhD, Csolnoky Ferenc Kórház, Veszprém, Hungary
  • Principal Investigator: Omar Freihat, Doctoral school of health sciences, Pécs University, Hungary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 12, 2016

Primary Completion (Actual)

August 9, 2019

Study Completion (Actual)

January 22, 2020

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 24, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pécs/ Oncoradiology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Variable used in the study.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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