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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04360993
Other study ID # Pécs/ Oncoradiology
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 12, 2016
Est. completion date January 22, 2020

Study information

Verified date December 2020
Source University of Pecs
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date January 22, 2020
Est. primary completion date August 9, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 41 Years to 88 Years
Eligibility 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 Design


Intervention

Radiation:
Radiotherapy
Patients have received radiotherapy as a treatment modality for Head and neck cancer

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Pecs

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in Apparent diffusion coefficient value between benign and malignant lesions 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
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