Biograph Vision 600 Versus Biograph Vision.X PET/CT
Intra-individual Comparison of PET Scans on the Biograph Vision 600 With the New Biograph Vision.X PET/CT
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started May 2025
Shorter than P25 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2025
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedFirst Posted
Study publicly available on registry
June 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
June 5, 2025
May 1, 2025
1.1 years
April 7, 2025
May 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change of physician's diagnostic confidence
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.
through study completion , an average of 1 year
Secondary Outcomes (1)
lowering of the radiotracer activity
through study completion , an average of 1 year
Study Arms (2)
Vision X
EXPERIMENTALPET/CT images acquired with Vision.X
Vision 600
ACTIVE COMPARATORPET/CT images in Vision 600
Interventions
Eligibility Criteria
You may qualify if:
- Written Inform Consent to participating.
- to 85 years of age
- Willing and able to comply with the requirements of the study, as judged by the investigator
You may not qualify if:
- Women in pregnancy
- Patients unable to lie still for the duration of the examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopitaux Universitaires de Genève
Geneva, 1205, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Pr Valentina Garibotto Head of the Division of nuclear medicine and molecular imaging, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of the Division of Nuclear Medicine and Molecular imaging, associate professor
Study Record Dates
First Submitted
April 7, 2025
First Posted
June 5, 2025
Study Start
May 1, 2025
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
May 30, 2026
Last Updated
June 5, 2025
Record last verified: 2025-05