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.
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.
Netherlands1 site, 1 recruiting
- Recruiting
Academisch ziekenhuis Maastricht
Maastricht, Limburg, 6229 HX
Sam Springer, MSc, +31433874907, sam.springer@mumc.nl
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:
- Validation of the FUR in 18F-FDG PET to accurately assess tumour metabolic activity Km.
- 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.
- Conditions
- Lung Cancer, Lymphoma
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted16 Dec 2022
- Study start15 Jan 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roel Wierts, Academisch Ziekenhuis Maastricht
- Investigators
- Roel Wierts, PhD, Principal investigator, Medical physicist
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Fractional Uptake Rate (FUR) in 18F-FDG PET/CT to Assess Tumour Metabolic Activity
- ClinicalTrials.gov ID
- NCT05654675
- Acronym / sponsor ID
- NL82359.068.22
- Conditions
- Lung Cancer, Lymphoma
- Keywords
- PET/CT, FDG, SUV, FUR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Academisch Ziekenhuis MaastrichtUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 16 Dec 2022 (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 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.
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:
- Validation of the FUR in 18F-FDG PET to accurately assess tumour metabolic activity Km.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncologic patients | – | Diagnostic Test: FDG PET/CTLymphoma 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Patients who receive an 18F FDG PET/CT scan as part of standard care
- Be competent and be 18 years of age or older
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| FDG PET/CTBesides the standard care FDG PET/CT examination, subjects receive a dynamic whole body PET/CT examination. | Diagnostic test | Oncologic patients |
Primary outcome
Superiority of the FUR compared to the SUV
Time frame: Time of PET examination
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
2 secondary outcomes
FUR validation to quantify tumour metabolic activity
Time frame: Time of PET examination
Impact of patient-specific input function
Time frame: Time of PET examination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Roel Wierts, PhD principal investigator
Medical physicist
1 site in 1 country: see every site and its status.
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.