Biograph Vision 600 Versus Biograph Vision.X PET/CT

May 27, 2025 updated by: Valentina Garibotto

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pr Valentina Garibotto Head of the Division of nuclear medicine and molecular imaging, MD
  • Phone Number: +41223727252
  • Email: valentina.garibotto@hug.ch

Study Locations

  • Switzerland
      • Genève, Switzerland, 1205
        • Recruiting
        • Hôpitaux Universitaires de Genève
        • Contact:
          • Pr Valentina Garibotto Head of Nuclear Medecine and molecular imaging
          • Phone Number: +41 3727252
          • Email: valentina.garibotto@hug.ch
        • Principal Investigator:
          • Valentina Garibotto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vision X
PET/CT images acquired with Vision.X
Device: Images
PET/CT images
Active Comparator: Vision 600
PET/CT images in Vision 600
Device: Images
PET/CT images

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion , an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion , an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valentina Garibotto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

May 27, 2025

First Posted (Estimated)

June 5, 2025

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-D00005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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