PET/MR Imaging in Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03739281
• Other study ID #: 2017/1952
• Status: Terminated
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• PET/MR
The included patients are imaged with PET/MR as part of the research protocol.
• PET/CT
The included patients are imaged with PET/CT as part of normal clinical routine.

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.