Organ Interaction Patterns in Healthy Individuals for Improved PET/CT Diagnostics

NCT05936411 | Unknown

• 1 other identifier: 1707/2022
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

PET/CT; Total-Body PET/CT; Inter-Organ connection

Outcome Measures

Primary Outcomes (2)

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

  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.

  6 Months

• Physiological Measurements from Apple i-Watch Wearable

  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),

  6 Months

Study Arms (1)

Healthy Subjects

OTHER

Device: Siemens Quadra PET/CT and [18F]FDG; Device: Apple i-Watch

Interventions

Siemens Quadra PET/CT and [18F]FDG DEVICE

The Siemens Quadra PET/CT, a clinically approved imaging device, is utilized in conjunction with the radiopharmaceutical tracer \[18F\]FDG in this study. The device allows for the acquisition of emission data across an extended axial field of view (axFOV) of 106 cm, covering an imaging range from the head to the thighs. The device's capabilities are leveraged to perform quantitative functional examinations of an extended axFOV. Subjects are scanned twice within a month for reproducibility standards. Each time, they are injected with 100MBq \[18F\]FDG and examined for 60 minutes in a dynamic scan. The tracer is used to build an atlas of normative glycolytic activities for most organs, excluding the brain. The glycolytic activities are measured as organ-based standardized uptake values. An ultra-low-dose CT scan is acquired to estimate mandatory attenuation correction factors.

Healthy Subjects

Apple i-Watch DEVICE

The Apple i-Watch, a wearable smart device, is used to continuously monitor physiological signals from the subjects. These signals include heart rate, steps and distance, calories burned, sleep tracking, blood oxygen saturation (SpO2), electrocardiogram (ECG), and workout tracking. Subjects are required to wear the Apple i-Watch for three months prior to the first PET scan and up to three months after the second PET scan. The data collected from the Apple i-Watch is paired with the FDG-PET image readouts to identify relationships between lifestyle and glucose uptakes during the scan.

Healthy Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult subjects

You may not qualify if:

• known presence of cancer
• pregnancy or breastfeeding
• On-site blood glucose level \> 150mg/dL
• Not able to lie still for 65 min

Sponsors & Collaborators

• Medical University of Vienna: lead

Central Study Contacts

Marcus Hacker, Prof., MD

CONTACT

43 140400; marcus.hacker@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Division of Nuclear Medicine

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 7, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: January 1, 2026
• Last Updated: July 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share