NCT05496920

Assessing Ultra-low Dose PET/CT and CT-less PET Using a Long Axial Field-of-view PET/CT System

Assessing the Clinical Acceptability of Ultra-low Dose PET/CT and CT-less PET Using a Long Axial Field-of-view PET/CT System: a Single-centre, Single-blinded Method Agreement Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Latest generation extended axial field-of-view (FOV) PET/CT systems offer the potential for substantial reductions in applied radiopharmaceutical necessary for a clinical scan. However, such low-dose examination protocols have yet to be robustly tested or demonstrated to be non-inferior. Furthermore, extended FOV scanners offer the potential for CT-less attenuation correction of the PET emission data, making clinically acceptable ultra-low dose examination protocols with radiation exposures of \< 1 millisievert possible for the first time. The aim of this study is to demonstrate the clinical acceptability of such low and ultra-low dose scanning protocols in a head-to-head prospective study against a full-dose scan using a regular FOV system

Detailed description

The first installation of a long-axial field-of-view (LAFOV) PET/CT system occurred in October 2020 at the department for nuclear medicine in Bern. This scanner along with recently introduced total-body scanners (TB-PET/CT) represent a substantial step forward in terms of nuclear medicine imaging technology. In conjunction with recent improvements in time-of-flight resolution and fully-digital detection technology, such systems offer surpassed sensitivity with improvements in image quality, lesion detection and diagnostic certainty. In contrast to LAFOV systems, standard axial field of view (SAFOV) scanners suffer from limited detection efficiency, where 90% of emitted photons go undetected owing to the ability to capture signal from only a small portion of the body (termed "bed position" or "bp"). However, while a number of studies are able to simulate lower applied radiopharmaceutical activities through the re-sampling of PET-sinogrammes or the rebinning of list-mode data, few studies adequately test the application of lower radiopharmaceutical activities, where limited data are available to justify the deviation from clinical routine. The clinical acceptability of such low-dose scans, in terms of lesion detection, image quality and lesion quantification is yet to be determined, which this study aims to address.

Conditions

• PET/CT

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FD-PET/CT	Standard of care PET/CT with full dose (FD) of the radiopharmaceutical
DIAGNOSTIC_TEST	LD-PET/CT	Additional low dose PET/CT performed within protocol defined time frame LD-PET/CT with additional ultra-low dose CT-less reconstruction

Timeline

• Start date: 2022-05-05
• Primary completion: 2024-08-08
• Completion: 2024-08-08
• First posted: 2022-08-11
• Last updated: 2024-10-03

Locations

1 site across 1 country: Switzerland