Back to resultsPET/MR Imaging in Lung Cancer
Primary Purpose
Lung Cancer
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
PET/MR
PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer
Eligibility Criteria
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.
Sites / Locations
- University Hospital of North Norway
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Nuclear medicine imaging
Arm Description
Patients undergo nuclear medicine imaging with PET/MR and PET/CT.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03739281
First Posted
October 30, 2018
Last Updated
January 13, 2023
Sponsor
University Hospital of North Norway
1. Study Identification
Unique Protocol Identification Number
NCT03739281
Brief Title
PET/MR Imaging in Lung Cancer
Official Title
Advancing Diagnosis and Treatment for Lung Cancer Patients Using Hybrid PET/MR Imaging and Novel Visualization Tools
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Internal resources ended
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nuclear medicine imaging
Arm Type
Other
Arm Description
Patients undergo nuclear medicine imaging with PET/MR and PET/CT.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/MR
Intervention Description
The included patients are imaged with PET/MR as part of the research protocol.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/CT
Intervention Description
The included patients are imaged with PET/CT as part of normal clinical routine.
Primary Outcome Measure Information:
Title
Sensitivity and specificity of PET/MR vs. clinical routine PET/CT
Description
Sensitivity and specificity of PET/MR scans will be compared with in clinical routine PET/CT examinations for lung cancer disease feature prediction.
Time Frame
1-2 weeks after the initial inclusion.
Secondary Outcome Measure Information:
Title
Prediction of treatment response and progression-free survival
Description
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.
Time Frame
1 year after inclusion.
Title
Prediction of treatment response and progression-free survival
Description
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.
Time Frame
2 years after inclusion.
Title
Prediction of treatment response and progression-free survival
Description
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.
Time Frame
5 years after inclusion.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rune Sundset, MD, PhD
Organizational Affiliation
University Hospital of North Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of North Norway
City
Tromsø
ZIP/Postal Code
9037
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
PET/MR Imaging in Lung Cancer
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