CancerNCT07006155
Biograph Vision 600 Versus Biograph Vision.X PET/CT
A study testing Images in people with Cancer and Alzheimer Disease, run by Valentina Garibotto at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer, Alzheimer Disease
- What is being tested?
- Images
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women in pregnancy
- Patients unable to lie still for the duration of the examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pr Valentina Garibotto Head of the Division of nuclear medicine and molecular imaging, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
Hopitaux Universitaires de Genève
Geneva, 1205
Pr Valentina Garibotto Head of Nuclear Medecine and molecular imaging, +41 3727252, valentina.garibotto@hug.ch
Valentina Garibotto
About this study
Official title: Intra-individual Comparison of PET Scans on the Biograph Vision 600 With the New Biograph Vision.X PET/CT
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.
- Conditions
- Cancer, Alzheimer Disease
- Being tested
- Images
- Keywords
- PET/CT, Vision, image quality, diagnostic performance
- Medical subject headings
- Neoplasms, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagesDevice
PET/CT images
| Study group | Role | What they receive |
|---|---|---|
| Vision X | Experimental | PET/CT images acquired with Vision.X Receives: Device: Images |
| Vision 600 | Active comparator | PET/CT images in Vision 600 Receives: Device: Images |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion , an average of 1 year
Secondary outcomes (1)
lowering of the radiotracer activity
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.
Measured: through study completion , an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 May 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valentina Garibotto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Valentina Garibotto, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006155
- Sponsor's protocol ID
- 2025-D00005
- Status last verified
- May 2025
- First submitted
- 7 Apr 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-individual Comparison of PET Scans on the Biograph Vision 600 With the New Biograph Vision.X PET/CT
- ClinicalTrials.gov ID
- NCT07006155
- Acronym / sponsor ID
- 2025-D00005
- Conditions
- Cancer, Alzheimer Disease
- Keywords
- PET/CT, Vision, image quality, diagnostic performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Valentina GaribottoUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 5 Jun 2025 (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 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vision X | Experimental | Device: ImagesPET/CT images acquired with Vision.X |
| Vision 600 | Active comparator | Device: ImagesPET/CT images in Vision 600 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Women in pregnancy
- Patients unable to lie still for the duration of the examination
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 |
|---|---|---|
| ImagesPET/CT images | Device | Vision 600, Vision X |
Primary outcome
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.
1 secondary outcome
lowering of the radiotracer activity
Time frame: through study completion , an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Pr Valentina Garibotto Head of the Division of nuclear medicine and molecular imaging, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Images in people with Cancer and Alzheimer Disease, run by Valentina Garibotto at 1 site in Switzerland.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pr Valentina Garibotto Head of the Division of nuclear medicine and molecular imaging, MD (+41223727252, valentina.garibotto@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of physician's diagnostic confidence (time frame: through study completion , an average of 1 year). 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 5 Jun 2025.