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Clinical Trials/NCT05936411
NCT05936411Not yet recruitingNot Applicable

Study to Determine Interaction Patterns of Different Organs in Healthy Volunteers as a Basis for Better Patient Diagnostics Using PET/CT Imaging

Medical University of Vienna0 sites50 target enrollmentStarted: September 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
50
Primary Endpoint
Physiological Measurements from Apple i-Watch Wearable

Study Overview

Brief Summary

The study titled "Study to determine interaction patterns of different organs in healthy volunteers as a basis for better patient diagnostics using PET/CT imaging" is designed to investigate the interaction patterns of different organs in healthy volunteers. The information gathered is intended to be leveraged to enhance patient diagnostics using PET/CT imaging techniques.

Detailed Description

In the study titled "Study to determine interaction patterns of different organs in healthy volunteers as a basis for better patient diagnostics using PET/CT imaging," the investigators will utilize the Biograph Quadra from Siemens Healthineers. This clinically approved PET-based imaging platform enables the acquisition of emission data across an extended axial field of view (axFOV) of 106 cm.

The objective is to leverage the Quadra PET/CT's capabilities, which can perform quantitative functional examinations of an extended axFOV, large enough to cover an imaging range from the head to the thighs. This range is typically scanned in standard oncology re/staging scenarios using multiple, overlapping bed positions.

The aim is to convert the Quadra PET's higher volume sensitivity into a higher signal-to-noise ratio and image quality, and significantly reduce the injected radioactivity while maintaining the diagnostic quality of the PET images. Notably, all organs within the extended axFOV are covered synchronously by the PET measurement, allowing the examination of inter-organ signalling, a key factor in disease onset and progression.

It is understood that diseases like cancer cause deviations from normal inter-organ communication (homeostasis). To depict such deviations in the future, the aim is to establish a reference standard. This involves building a voxel-wise normative database of glycolytic activity across organs covered in the axFOV imaging range, which requires the acquisition of dynamic FDG-PET data of normal, disease-free individuals.

Additionally, the investigators seek to pair the FDG-PET image readouts with continuous physiological signals from an Apple i-watch wearable for identifying relationships between lifestyle and glucose uptakes during the scan. The objective is to build a normative database of voxel- and organ-based glycolytic uptake in 50 healthy volunteers. Subjects will be scanned twice for reproducibility standards and will wear a smartwatch for 3 months prior to the first PET scan and up to 3 months after the 2nd PET scan.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Adult subjects

Exclusion Criteria

  • •Age < 18, common exclusion criteria for PET/CT scans
  • •known presence of cancer
  • •pregnancy or breastfeeding
  • •On-site blood glucose level > 150mg/dL
  • •Not able to lie still for 65 min

Arms & Interventions

Healthy Subjects

Other

Intervention: Siemens Quadra PET/CT and [18F]FDG (Device)

Healthy Subjects

Other

Intervention: Apple i-Watch (Device)

Outcomes

Primary Outcomes

Physiological Measurements from Apple i-Watch Wearable

Time Frame: 6 Months

The secondary outcome measure is the physiological measurements collected from the Apple i-Watch wearable worn by the participants. These measurements include heart rate, steps and distance, calories burned, sleep tracking, blood oxygen saturation (SpO2),

Standardized Uptake Value (SUV) in gm/ml in Healthy Volunteers

Time Frame: 6 Months

The primary outcome measure is the Standardized Uptake Value (SUV) in gm/ml, which is a measure of the image-derived radioactivity concentration and the whole body concentration of the injected radioactivity. The SUV will be reported as Mean and Standard Deviation. This measure will provide preliminary data about total body FDG perfusion and early biodistribution in a cohort of healthy volunteers. The SUV is calculated from the PET/CT scans using the Siemens Quadra PET/CT and \[18F\]FDG as the tracer.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Univ.-Prof. Dr. Marcus Hacker

Head of the Division of Nuclear Medicine

Medical University of Vienna

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