PET/MR Imaging in Lung Cancer

NCT03739281 | Terminated

• 1 other identifier: 2017/1952
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Prediction of treatment response and progression-free survival

  1 year after inclusion.

• Prediction of treatment response and progression-free survival

  2 years after inclusion.

• Prediction of treatment response and progression-free survival

  5 years after inclusion.

Study Arms (1)

Nuclear medicine imaging

OTHER

Patients undergo nuclear medicine imaging with PET/MR and PET/CT.

Diagnostic Test: PET/MR; Diagnostic Test: PET/CT

Interventions

PET/MR DIAGNOSTIC_TEST

The included patients are imaged with PET/MR as part of the research protocol.

Nuclear medicine imaging

PET/CT DIAGNOSTIC_TEST

The included patients are imaged with PET/CT as part of normal clinical routine.

Nuclear medicine imaging

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

University Hospital of North Norway

Tromsø, 9037, Norway

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Rune Sundset, MD, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 13, 2018
• Study Start: December 12, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

NO (1)