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Lung CancerNCT05654675

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

An observational study of Lung Cancer and Lymphoma, run by Academisch Ziekenhuis Maastricht at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Lymphoma
What is being tested?
FDG PET/CT
How many people
30 participants
Where
1 siteNetherlands
Study dates
15 Jan 2024to 1 Jun 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sam Springer, MSc contact

+31433874907

sam.springer@mumc.nl

Netherlands1 site, 1 recruiting
  • Academisch ziekenhuis Maastricht

    Maastricht, Limburg, 6229 HX

    Sam Springer, MSc, +31433874907, sam.springer@mumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Evaluation of the Fractional Uptake Rate (FUR) in 18F-FDG PET/CT to Assess Tumour Metabolic Activity

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.

Being tested
FDG PET/CT
Keywords
PET/CT, FDG, SUV, FUR
Medical subject headings
Lung Neoplasms, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FDG PET/CTDiagnostic test

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

Study groups in NCT05654675
Study groupRoleWhat they receive
Oncologic patientsLymphoma 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
Receives: Diagnostic Test: FDG PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Time of PET examination

Secondary outcomes (2)
  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

    Measured: 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

    Measured: Time of PET examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2022
  2. Study start15 Jan 2024
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05654675
Sponsor's protocol ID
NL82359.068.22
Status last verified
Jan 2025
First submitted
8 Dec 2022
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer and Lymphoma, run by Academisch Ziekenhuis Maastricht at 1 site in Netherlands.

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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. 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 Netherlands. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sam Springer, MSc (+31433874907, sam.springer@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Superiority of the FUR compared to the SUV (time frame: Time of PET examination). 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 29 Jan 2025.

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