Lung CancerNCT03739281
PET/MR Imaging in Lung Cancer
A study testing PET/MR and PET/CT in people with Lung Cancer, run by University Hospital of North Norway at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- PET/MR and PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNorway
- Study dates
- 12 Dec 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Referred to clinical PET/CT examination for investigation of lung disease.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advancing Diagnosis and Treatment for Lung Cancer Patients Using Hybrid PET/MR Imaging and Novel Visualization Tools
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- PET/MR, PET/CT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRDiagnostic test
The included patients are imaged with PET/MR as part of the research protocol.
PET/CTDiagnostic test
The included patients are imaged with PET/CT as part of normal clinical routine.
| Study group | Role | What they receive |
|---|---|---|
| Nuclear medicine imaging | Other | Patients undergo nuclear medicine imaging with PET/MR and PET/CT. Receives: Diagnostic Test: PET/MR; Diagnostic Test: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 weeks after the initial inclusion.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 5 years after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start12 Dec 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Internal resources ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rune Sundset, MD, PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739281
- Sponsor's protocol ID
- 2017/1952
- Status last verified
- Jan 2023
- First submitted
- 30 Oct 2018
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Diagnosis and Treatment for Lung Cancer Patients Using Hybrid PET/MR Imaging and Novel Visualization Tools
- ClinicalTrials.gov ID
- NCT03739281
- Acronym / sponsor ID
- 2017/1952
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal resources ended
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nuclear medicine imaging | Other | Diagnostic Test: PET/MR, Diagnostic Test: PET/CTPatients undergo nuclear medicine imaging with PET/MR and PET/CT. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Referred to clinical PET/CT examination for investigation of lung disease.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MRThe included patients are imaged with PET/MR as part of the research protocol. | Diagnostic test | Nuclear medicine imaging |
| PET/CTThe included patients are imaged with PET/CT as part of normal clinical routine. | Diagnostic test | Nuclear medicine imaging |
Primary outcome
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.
3 secondary outcomes
Prediction of treatment response and progression-free survival
Time frame: 1 year after inclusion.
Prediction of treatment response and progression-free survival
Time frame: 2 years after inclusion.
Prediction of treatment response and progression-free survival
Time frame: 5 years after inclusion.
Results and safety
The study was stopped early (reason given: Internal resources ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rune Sundset, MD, PhD principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MR and PET/CT in people with Lung Cancer, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Internal resources ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of PET/MR vs. clinical routine PET/CT (time frame: 1-2 weeks after the initial inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.