Cancer, Alzheimer Disease
Conditions
Keywords
PET/CT, Vision, image quality, diagnostic performance
Brief summary
The main purpose is to evaluate initial clinical experiences and to explore whether the Vision.X system yields improved image quality and diagnostic performance compared to Vision 600.
Interventions
DEVICEImages
PET/CT images
Sponsors
Valentina Garibotto
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Written Inform Consent to participating. * 18 to 85 years of age * Willing and able to comply with the requirements of the study, as judged by the investigator
Exclusion criteria
* Women in pregnancy * Patients unable to lie still for the duration of the examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of physician's diagnostic confidence | through study completion , an average of 1 year | The primary outcome will be image quality assessed on the two compared PET systems, namely Vision and Vision X. For the all PET scans, three independent, blinded physicians will evaluate the scans and establish diagnoses. They will assess the following quality criteria using 5-point Likert scales: * Overall Image Quality: 1 = poor, 5 = excellent, * Image Noise: 1 = excessive noise, 5 = no perceptible noise, Image quality is associated with physician's diagnostic confidence and with the ability to detect smaller lesions that can lead to more accurate staging of diseases, particularly in oncology and neurology. This enhanced staging can influence treatment decisions, allowing healthcare professionals to tailor interventions based on a more precise understanding of the extent and location of the disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lowering of the radiotracer activity | through study completion , an average of 1 year | The secondary outcome will be the assessment of image quality (as for the primary outcome) on simulated lower doses of radiotracer activity on both PET systems (Vision and Vision X). To assess this, the same parameters described in section 5.1 will be evaluated across different emulated scan times, as shorter scanning times allow simulating lower administered activities. These will be generated by binning the list-mode data with varying frame durations for both scanner acquisitions. The lowering of the radiotracer activity maintaining a high-quality image is relevant for its capacity to reduce the radiation exposure for the patients and contributes to optimizing healthcare resources. |
Countries
Switzerland
Contacts
Primary ContactPr Valentina Garibotto Head of the Division of nuclear medicine and molecular imaging, MD
Outcome results
None listed