HealthyHealthy-PETNCT05936411
Organ Interaction Patterns in Healthy Individuals for Improved PET/CT Diagnostics
A study testing Siemens Quadra PET/CT and [18F]FDG and Apple i-Watch in people with Healthy, run by Medical University of Vienna.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Siemens Quadra PET/CT and [18F]FDG and Apple i-Watch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult subjects
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study to Determine Interaction Patterns of Different Organs in Healthy Volunteers as a Basis for Better Patient Diagnostics Using PET/CT Imaging
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.
Read the 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.
The hypothesis is that an atlas of normative glycolytic activities can be built with a test-retest variability of <15% (measured as organ-based standardized uptake value). The methodology involves using the Siemens Quadra PET/CT. Subjects come for test-retest within a month. Each time they will be injected 100MBq [18F]FDG and examined for 60 min (dynamic scan). An ultra-low-dose CT scan will be acquired to estimate mandatory attenuation correction factors.
No risks or adverse device effects are expected as the Quadra PET/CT is approved for clinical use.
- Conditions
- Healthy
- Being tested
- Siemens Quadra PET/CT and [18F]FDG, Apple i-Watch
- Keywords
- PET/CT, Total-Body PET/CT, Inter-Organ connection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siemens Quadra PET/CT and [18F]FDGDevice
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.
Apple i-WatchDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Other | Not described Receives: Device: Siemens Quadra PET/CT and [18F]FDG; Device: Apple i-Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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),
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ.-Prof. Dr. Marcus Hacker, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936411
- Sponsor's protocol ID
- 1707/2022
- Acronym
- Healthy-PET
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine Interaction Patterns of Different Organs in Healthy Volunteers as a Basis for Better Patient Diagnostics Using PET/CT Imaging
- ClinicalTrials.gov ID
- NCT05936411
- Acronym / sponsor ID
- Healthy-PET / 1707/2022
- Conditions
- Healthy
- Keywords
- PET/CT, Total-Body PET/CT, Inter-Organ connection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 7 Jul 2023 (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 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.
The hypothesis is that an atlas of normative glycolytic activities can be built with a test-retest variability of <15% (measured as organ-based standardized uptake value). The methodology involves using the Siemens Quadra PET/CT. Subjects come for test-retest within a month. Each time they will be injected 100MBq [18F]FDG and examined for 60 min (dynamic scan). An ultra-low-dose CT scan will be acquired to estimate mandatory attenuation correction factors.
No risks or adverse device effects are expected as the Quadra PET/CT is approved for clinical use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Other | Device: Siemens Quadra PET/CT and [18F]FDG, Device: Apple i-Watch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult subjects
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Siemens Quadra PET/CT and [18F]FDGThe 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. | Device | Healthy Subjects |
| Apple i-WatchThe 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. | Device | Healthy Subjects |
Primary outcome
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.
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),
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Siemens Quadra PET/CT and [18F]FDG and Apple i-Watch in people with Healthy, run by Medical University of Vienna.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcus Hacker, Prof., MD (43 140400 ext. 55310, marcus.hacker@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Uptake Value (SUV) in gm/ml in Healthy Volunteers (time frame: 6 Months). The study lists 2 primary outcomes in all. 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 7 Jul 2023.