- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03739281
PET/MR Imaging in Lung Cancer
Advancing Diagnosis and Treatment for Lung Cancer Patients Using Hybrid PET/MR Imaging and Novel Visualization Tools
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Tromsø, Norway, 9037
- University Hospital of North Norway
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Nuclear medicine imaging
Patients undergo nuclear medicine imaging with PET/MR and PET/CT.
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The included patients are imaged with PET/MR as part of the research protocol.
The included patients are imaged with PET/CT as part of normal clinical routine.
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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
Time Frame: 1-2 weeks after the initial inclusion.
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Sensitivity and specificity of PET/MR scans will be compared with in clinical routine PET/CT examinations for lung cancer disease feature prediction.
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1-2 weeks after the initial inclusion.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prediction of treatment response and progression-free survival
Time Frame: 1 year after inclusion.
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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.
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1 year after inclusion.
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Prediction of treatment response and progression-free survival
Time Frame: 2 years after inclusion.
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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.
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2 years after inclusion.
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Prediction of treatment response and progression-free survival
Time Frame: 5 years after inclusion.
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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.
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5 years after inclusion.
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Collaborators and Investigators
Investigators
- Principal Investigator: Rune Sundset, MD, PhD, University Hospital of North Norway
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/1952
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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