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Role of PET/MRI in Head and Neck Cancer

Sponsor
University of Pecs (Other)
Overall Status
Completed
CT.gov ID
NCT04360993
Collaborator
(none)
110
Enrollment
45.3
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: Radiotherapy

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 Design

Study Type:
Observational
Actual Enrollment :
110 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
PET/CT and PET/MRI Based Treatment Modalities in the Modern Oncology
Actual Study Start Date :
Apr 12, 2016
Actual Primary Completion Date :
Aug 9, 2019
Actual Study Completion Date :
Jan 22, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Difference in Apparent diffusion coefficient value between benign and malignant lesions [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
41 Years to 88 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Omar Freihat, Clinical investigator., University of Pecs
ClinicalTrials.gov Identifier:
NCT04360993
Other Study ID Numbers:
  • Pécs/ Oncoradiology
First Posted:
Apr 24, 2020
Last Update Posted:
Dec 29, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms

Study Results

No Results Posted as of Dec 29, 2020