Role of PET/MRI in Head and Neck Cancer

NCT04360993 | Completed

• 1 other identifier: Pécs/ Oncoradiology
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Head and Neck Cancer; Benign Neoplasm; Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Radiotherapy RADIATION

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

Patients underwent PET/CT & PET/MRI

Eligibility Criteria

• Age: 41 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pecs: lead

Related Publications (2)

• 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.

  PMID: 33640578 DERIVED

• 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.

  PMID: 32771060 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Arpad Kovacs, MD, PhD

  University of Pecs

  STUDY DIRECTOR

• Cselik Zsolt, MD, PhD

  Csolnoky Ferenc Kórház, Veszprém, Hungary

  STUDY CHAIR

• Omar Freihat

  Doctoral school of health sciences, Pécs University, Hungary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical investigator.

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 24, 2020
• Study Start: April 12, 2016
• Primary Completion: August 9, 2019
• Study Completion: January 22, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR