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

NCT05654675 | Recruiting DMC

• 1 other identifier: NL82359.068.22
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Lymphoma

Keywords

PET/CT; FDG; SUV; FUR

Outcome Measures

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 of PET examination

Secondary Outcomes (2)

• FUR validation to quantify tumour metabolic activity

  Time of PET examination

• Impact of patient-specific input function

  Time of PET examination

Study Arms (1)

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

FDG PET/CT DIAGNOSTIC_TEST

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

Oncologic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht: lead

Study Sites (1)

Academisch ziekenhuis Maastricht

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Lymphoma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Roel Wierts, PhD

  Medical physicist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam Springer, MSc

CONTACT

+31433874907; sam.springer@mumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical physicist

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: January 15, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

NL (1)