18F-FDG: Patients will receive a single intravenous injection of 3 MBq/kg 18F-FDG
PET/CT imaging: Patient will undergo 2 CT acquisitions and multiple PET emission scans.
Study summary
Indeterminate lung nodules (6-15mm) are frequent findings in patients undergoing chest CT scanning, but adequate follow-up imaging is currently not in place to facilitate early detection, diagnosis and decision making regarding treatment.
The introduction of long Field-Of-View PET/CT scanners could make a difference in this matter due to the substantial increase in sensitivity allowing optimal image quality. Whether this new technology could provide improved detection and follow-up of indeterminate lung nodules is what we aim to explore in this study.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria:
* able to give informed consent
* signed informed consent
* confirmed indeterminate lung nodule(s) of 6-15 mm in size on CT chest imaging
* routine 18F-FDG PET/CT performed
* scheduled for biopsy or resection of the lung nodules
Exclusion Criteria:
* claustrophobia
* pregnant or breastfeeding
* interval of at least 2 weeks between PET scan and last date of systemic anti-cancer therapy to reduce false-negative uptake in lesions
* radiation therapy of the target lung nodule(s)
* uncontrolled diabetes mellitus
* any medical condition potentially hampering conduction of the trial
Primary outcome measure(s)
Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration, post-processing filtering) static whole-body acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis. — up to 2 years Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration, post-processing filtering) static whole-body acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis.
Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration) dynamic whole-body acquisition and reconstruction protocol by performing kinetic modelling (Patlak, Ki) analysis. — up to 2 years Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration) dynamic whole-body acquisition and reconstruction protocol by performing kinetic modelling (Patlak, Ki) analysis.
Description of optimized breath-hold acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis and compare with outcomes 1 and 2. — up to 2 years Description of optimized breath-hold acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis and compare with outcomes 1 and 2.
Trial sites (1)
Facility
City
Region
Status
University Medical Center Groningen
Groningen
Netherlands
Recruiting
More University Medical Center Groningen trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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