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PET/MR Imaging in Lung Cancer

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ClinicalTrials.gov Identifier: NCT03739281
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Diagnostic Test: PET/MR Diagnostic Test: PET/CT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Advancing Diagnosis and Treatment for Lung Cancer Patients Using Hybrid PET/MR Imaging and Novel Visualization Tools
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Sensitivity and specificity of PET/MR vs. clinical routine PET/CT [ Time Frame: 1-2 weeks after the initial inclusion. ]
    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 :
  1. Prediction of treatment response and progression-free survival [ Time Frame: 1 year after inclusion. ]
    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.

  2. Prediction of treatment response and progression-free survival [ Time Frame: 2 years after inclusion. ]
    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.

  3. Prediction of treatment response and progression-free survival [ Time Frame: 5 years after inclusion. ]
    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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739281


Contacts
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Contact: Rune Sundset, MD, PhD +47 - 97141456 rune.sundset@unn.no
Contact: Samuel Kuttner, Msc +47 - 77669953 samuel.kuttner@uit.no

Locations
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Norway
University Hospital of North Norway Recruiting
Tromsø, Norway, 9037
Contact: Rune Sundset    +47 - 97 14 14 56    rune.sundset@unn.no   
Contact: Samuel Kuttner    +47 - 77 66 99 53    samuel.kuttner@uit.no   
Sponsors and Collaborators
University Hospital of North Norway
Investigators
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Principal Investigator: Rune Sundset, MD, PhD University Hospital of North Norway

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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT03739281     History of Changes
Other Study ID Numbers: 2017/1952
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases