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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Lung Cancer
• Intervention / Treatment: Diagnostic test: FDG PET/CT

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Sam Springer, MSc; Phone Number: +31433874907; Email: sam.springer@mumc.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Recruiting
      • Academisch Ziekenhuis Maastricht
      • Contact: Sam Springer, MSc; Phone Number: +31433874907; Email: sam.springer@mumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• 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.

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Besides the standard care FDG PET/CT examination, subjects receive a dynamic whole body PET/CT examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 of PET examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 of PET examination

Collaborators and Investigators

• Sponsor: Academisch Ziekenhuis Maastricht
• Investigators: Principal Investigator: Roel Wierts, PhD, Medical physicist

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: PET/CT; FDG; SUV; FUR
• Other Study ID Numbers: NL82359.068.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No