Intra-individual Comparison of PET Scans on the Biograph Vision 600 With the New Biograph Vision.X PET/CT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- change of physician's diagnostic confidence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Vision X
PET/CT images acquired with Vision.X
Intervention: Images (Device)
Vision 600
PET/CT images in Vision 600
Intervention: Images (Device)
Outcomes
Primary Outcomes
change of physician's diagnostic confidence
Time Frame: 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 Outcomes
- lowering of the radiotracer activity(through study completion , an average of 1 year)
Investigators
Valentina Garibotto
Director of the Division of Nuclear Medicine and Molecular imaging, associate professor
University Hospital, Geneva