PET/MR Imaging in Lung Cancer

Advancing Diagnosis and Treatment for Lung Cancer Patients Using Hybrid PET/MR Imaging and Novel Visualization Tools

The purpose of this project is to investigate if PET/MR imaging improves the accuracy in visualization and characterization of lung cancer disease, compared to PET/CT.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: PET/MR; Diagnostic test: PET/CT

Detailed Description

Lung cancer is the most frequent cancer type and the leading cause of cancer-related death worldwide. Positron emission tomography (PET) coupled with computed tomography (CT) is the standard of care for visualization and staging of lung cancer. Recent clinical introduction of hybrid PET and magnetic resonance (MR) imaging systems has shown potential to improve tumor imaging beyond the limits of PET/CT. However, knowledge about the clinical impact of this new hybrid modality is still limited.

This project aims to investigate how PET/MR may improve the diagnosis and treatment of lung cancer disease, compared to PET/CT: PET/MR may allow early detection of brain and liver metastases, which strongly affects treatment outcome and survival; predictive models based on machine learning may combine image derived biomarkers from PET/MR, histology and health record data, to automatically visualize and characterize the tumor, facilitating computer aided diagnosis and personalized radiotherapy treatment.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Tromsø, Norway, 9037
    • University Hospital of North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Referred to clinical PET/CT examination for investigation of lung disease.

Exclusion Criteria:

• Blood glucose level >8.3 mmol/l
• MR incompatible objects, e.g. metal implants, inside the body
• Intolerance to gadolinium-based contrast agents, e.g. severe renal disease (GFR<30).
• Unable to give written consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Nuclear medicine imaging; Patients undergo nuclear medicine imaging with PET/MR and PET/CT.	Diagnostic test: PET/MR; The included patients are imaged with PET/MR as part of the research protocol.; Diagnostic test: PET/CT; The included patients are imaged with PET/CT as part of normal clinical routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of PET/MR vs. clinical routine PET/CT	Sensitivity and specificity of PET/MR scans will be compared with in clinical routine PET/CT examinations for lung cancer disease feature prediction.	1-2 weeks after the initial inclusion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of treatment response and progression-free survival	We will investigate which PET/MR or PET/CT features are best suited as an imaging biomarker for treatment response evaluation and for progression-free survival 1 year after inclusion.	1 year after inclusion.
Prediction of treatment response and progression-free survival	We will investigate which PET/MR or PET/CT features are best suited as an imaging biomarker for treatment response evaluation and for progression-free survival 2 years after inclusion.	2 years after inclusion.
Prediction of treatment response and progression-free survival	We will investigate which PET/MR or PET/CT features are best suited as an imaging biomarker for treatment response evaluation and for progression-free survival 5 years after inclusion.	5 years after inclusion.

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Investigators: Principal Investigator: Rune Sundset, MD, PhD, University Hospital of North Norway

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2017/1952

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No