Clinical trial NCT05496920: Assessing Ultra-low Dose PET/CT and CT-less PET Using a Long Axial Field-of-view PET/CT System
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PET/CT
Keywords: PET/CT, low dose, long-axial field-of-view, extended field-of-view, total-body PET
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will receive first a standard of care PET/CT and then an additional low dose PET/CT. The low dose PET/CT will be reconstructed using a standard CT for attenuation correction (LD-PET/CT) and with a novel CT-less method using transmission data (ultra low dose ULD-PET/CT).
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adults (\>18 years) able to provide informed consent for inclusion, willing and able to undergo a PET/CT for the detection or staging of cancer.
* Individuals undergoing a PET/CT with 18F-FDG for the investigation of known or suspected NSCLC.
* Upper fasting plasma glucose levels of \<8.3 mmol/L (\<150 mg/dL) (as measured \>30 mins prior to the administration of the radiopharmaceutical).

Exclusion Criteria:

* Patients who are unable to consent to a second study-specific examination
* Patients with claustrophobia requiring medication.
* Patients who commence active treatment of a cancer or other pathology between scans.
* Patients who have not fasted for \> 4 hours prior to the study.
* Insulin dependent diabetics.

Primary outcomes:
measure: Intra-rater correlation coefficient
timeFrame: 2-6 weeks following scan
Secondary outcomes:
measure: Intra-rater correlation coefficient
timeFrame: 2-6 weeks following scan
measure: Lesion uptake
timeFrame: 2-6 weeks following scan
measure: Image quality
timeFrame: 2-6 weeks following scan
measure: Subjective quality
timeFrame: 2-6 weeks following scan
measure: Agreement
timeFrame: 2-6 weeks following scan
measure: Diagnostic accuracy
timeFrame: 2-6 weeks following scan
Other outcomes:
measure: Acceptability
timeFrame: 2-6 weeks following scan
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern
Study officials:
affiliation: Inselspital
name: Axel O Rominger, MD
role: STUDY_CHAIR
References: