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Recruiting

NCT Number: NCT07006155

Biograph Vision 600 Versus 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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopitaux Universitaires de Genève

Geneva, 1205, Switzerland

Location status: Recruiting

Location contact

Pr Valentina Garibotto Head of Nuclear Medecine and molecular imaging

CONTACT

[email protected]

+41 3727252

Valentina Garibotto

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Images

Device

PET/CT images

Primary outcomes

  1. 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

  1. lowering of the radiotracer activity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pr Valentina Garibotto Head of the Division of nuclear medicine and molecular imaging, MD

CONTACT

[email protected]

+41223727252

Sponsors and collaborators

Lead sponsor

Valentina Garibotto

Other

Registry information

Official study title

Intra-individual Comparison of PET Scans on the Biograph Vision 600 With the New Biograph Vision.X PET/CT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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