An observational study in Lung Cancer and Lymphoma, sponsored by Academisch Ziekenhuis Maastricht. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Academisch Ziekenhuis Maastricht · Observational
The goal of this study is to evaluate the use of new method to quantify the amount of sugar a tumor consumes using PET/CT. The main questions it aims to answer are:
Participants who will undergo a standard care FDG PET/CT scan will in additional receive a dynamic PET/CT scan prior to the standard care scan. In addition blood samples will be drawn at three time points during the examination.
As most tumours have a high glucose consumption, important information on tumour metabolism can be obtained from PET imaging using 18F-FDG as a radioactive glucose analogue. From literature it is known that quantitative analysis improves the clinical value of 18F-FDG PET. However, instead of measuring the true tumour glucose consumption Km, in current clinical practice the 18F-FDG uptake is measured at a certain time after administration as a surrogate for Km, the so-called standardized uptake value (SUV). As the SUV suffers from a number of important shortcomings, discrepancies between Km and the SUV have been reported which may lead to erroneous conclusions regarding disease progression based on the SUV.
Alternatively, pharmacokinetic modelling approaches facilitate accurate Km assessment. Unfortunately, these approaches typically require complex mathematical modelling, lengthy dynamic PET imaging and/or invasive arterial blood sampling and are therefore not compatible to current clinical oncologic 18F-FDG PET scanning. However, from these models it can be derived that at late time points after administration Km can be approximated using a simplified approach known as the fractional uptake rate (FUR). Our hypothesis is that the correlation between the FUR and Km is superior compared to the correlation between the SUV and Km. Therefore we expect that quantification of 18F-FDG PET images based on the FUR is superior to SUV quantifications.
The results of this study may therefore lead to a new and improved method to quantify oncologic PET images which may enhance the diagnostic value of PET. In particular, this method may lead to a more accurate assessment of tumour response to therapy and may therefore prevent continuation of unsuccessful therapy or termination of a successful therapy.
Primary objective:
To investigate whether the correlation between the FUR and Km is superior compared to the correlation between the SUV and Km.
Secondary objectives:
The risks and patient discomfort associated with this scientific study are low. Only patients are included who already receive an 18F-FDG PET/CT scan as part of standard care.
Instead of resting on a standard hospital bed for one hour after 18F-FDG injection, patients will be resting inside the PET/CT system while a dynamic PET acquisition is performed.
In addition to their standard PET/CT examination, an extra low-dose attenuation CT scan will be performed resulting in an added radiation exposure of the patient of 3.6 mSv.
Moreover, three additional venous blood samples will be obtained at three time points, one before and two after 18F-FDG administration will be obtained from the patient.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 30 is below the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Academisch Ziekenhuis Maastricht is the lead sponsor of 23 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A total of 30 oncologic patients who will receive an 18F-FDG PET/CT scan as part of standard care will participate in this study. Therefore, recruitment of participants will take place among oncologic patients who are referred to the department of radiology and nuclear medicine of the MUMC+ for an 18F-FDG PET/CT examination.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Lymphoma and lung cancer patients will undergo an additional dynamic FDG PET/CT examination on top of their standard care PET/CT examination. In addition, blood samples will be drawn at three time points
Diagnostic Test: FDG PET/CT
Besides the standard care FDG PET/CT examination, subjects receive a dynamic whole body PET/CT examination.
Superiority of the FUR compared to the SUV
The correlation between the fractional uptake rate (FUR) and the metabolic glucose consumption (Km) will be compared to the correlation between the standardized uptake value (SUV) and Km
Time frame: Time of PET examination
FUR validation to quantify tumour metabolic activity
Comparison between the assessment of the tumour metabolic activity as measured by the FUR vs traditional Patlak method
Time frame: Time of PET examination
Impact of patient-specific input function
The impact of the use of a patient-specific input function is investigated compared to the use of a (scaled) population-based input function on the accuracy of Km assessment using the FUR
Time frame: Time of PET examination
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Apr 2025, 14 months after the start.
Of 591 non-industry observational studies under Lung Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 162. This study's planned 14 months is below that.
Counting every sponsor, half of 681 studies reached it within 57 months; a quarter within 25 and three quarters within 135.
How these figures are worked out, and which studies are left out of them.
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Academisch Ziekenhuis Maastricht