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RecruitingNCT05654675Updated Jan 29, 2025

Evaluation of the Use of the FUR to Quantify Tumor Glucose Consumption in Oncologic PET

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

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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:

  • Is the new quantification method superior with respect to the method currently used in the clinic?
  • Does the new quantification method provide accurate assessment of the sugar consumption of tumours?

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.

Read the detailed description

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:

  1. Validation of the FUR in 18F-FDG PET to accurately assess tumour metabolic activity Km.
  2. To investigate the impact of the use of patient-specific versus a (scaled) population-based input function on the accuracy of Km assessment using the FUR.

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.

02

Conditions studied

  • Lung Cancer
  • Lymphoma

Keywords

  • PET/CT
  • FDG
  • SUV
  • FUR
03

In context

Lung Neoplasms

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  • Patients who receive an 18F FDG PET/CT scan as part of standard care
  • Be competent and be 18 years of age or older

Exclusion criteria

Exclusion Criteria:

  • Diabetes (fasted blood glucose > 7 mmol/L)
  • Not fasted > 4 hours
  • Physical exercise within 24 hours
  • Earlier treatment for carcinoma with radio/chemo-therapy
  • Active inflammation (fever > 38 degrees, CRP > 5)
  • Any condition or medical indication (such as claustrophobia) that indicates that the patient will not be able to lie still for the duration of the dynamic PET/CT examination
  • Pregnant or breast feeding
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Oncologic patients

    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

Interventions

  • Diagnostic testFDG PET/CT

    Besides the standard care FDG PET/CT examination, subjects receive a dynamic whole body PET/CT examination.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Dec 8, 2022
First posted
Dec 16, 2022
StartActual
Jan 15, 2024
Primary completionEst.
Apr 1, 2025
CompletionEst.
Jun 1, 2025
Last update
Jan 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05654675
Lead sponsor
Academisch Ziekenhuis Maastricht
Responsible party
Roel Wierts (Medical physicist, Academisch Ziekenhuis Maastricht) — Principal investigator
First posted
Dec 16, 2022
Start date
Jan 15, 2024
Primary completion
Apr 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Jan 29, 2025

Study contacts

Sam Springer, MSc
Contact
sam.springer@mumc.nl
+31433874907
Roel Wierts, PhD
principal investigator · Medical physicist

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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