- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04360993
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
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
|
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
Investigators
- Study Director: Arpad Kovacs, MD, PhD, University of Pécs
- 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
- Freihat O, Toth Z, Pinter T, Kedves A, Sipos D, Cselik Z, Lippai N, Repa I, Kovacs A. Pre-treatment PET/MRI based FDG and DWI imaging parameters for predicting HPV status and tumor response to chemoradiotherapy in primary oropharyngeal squamous cell carcinoma (OPSCC). Oral Oncol. 2021 May;116:105239. doi: 10.1016/j.oraloncology.2021.105239. Epub 2021 Feb 25.
- Freihat O, Pinter T, Kedves A, Sipos D, Cselik Z, Repa I, Kovacs A. Diffusion-Weighted Imaging (DWI) derived from PET/MRI for lymph node assessment in patients with Head and Neck Squamous Cell Carcinoma (HNSCC). Cancer Imaging. 2020 Aug 8;20(1):56. doi: 10.1186/s40644-020-00334-x.
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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