Skip to content

Evaluation of a new PET/CT scanner

Clinical evaluation of long axial field-of-view PET/CT imaging - LAFOV PET/CT

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58263
Enrollment
55
Registered
2025-10-10
Start date
2026-01-07
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PET image quality of a LAFOV PET/CT scanner compared to a standard SAFOV PET/CT scanner in patients with metabolic tissue activity, neuroendocrine tumors and other somatostatin receptor-positive tumors, prostate cancer and liver cancer Evaluation of PET/CT image quality in patients with high tissue activity and common cancers, including hormone-related tumors, prostate cancer, and liver cancer

Interventions

The Omni Legend 128 is an advanced PET/CT system developed by GE HealthCare, featuring an extended axial field-of-view (LAFOV) of 128 cm. Equipped with fully digital detectors and deep crystals (30 mm

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Aged 18 years or above Referred for a diagnostic PET/CT examination with [18F]FDG, [68Ga]DOTATATE, 68Ga]PSMA, or Y90-microspheres Capable to provide written informed consent 

Exclusion criteria

Exclusion criteria: Diagnostic CT with administration of a contrast agent required Claustrophobia affecting the patient to the extent that lying in the scanner for any additional period of time is not feasible. Inability to remain still for the duration of the PET/CT examinations Known or suspected pregnancy 

Design outcomes

Primary

MeasureTime frame
Primary study parameter(s) Difference in image quality between LAFOV PET/CT images and reference PET/CT will be assessed by comparing rated image quality scores (Likert scale, 1 – 5) using a Wilcoxon signed-rank test. Patients with missing outcome values will be excluded.

Secondary

MeasureTime frame
Difference in lesion conspicuity and image noise between LAFOV PET/CT images and reference PET/CT will be assessed by comparing rated visual lesion conspicuity scores (Likert scale, 1 – 5) and image noise scores (Likert scale, 1 – 5) using Wilcoxon signed-rank tests. Difference in quantitative PET tracer uptake values (SUVmax, SUVmean and SUV ratio’s) between LAFOV PET/CT and reference PET/CT in normal organs and lesions will be assessed using paired samples t-tests or Wilcoxon signed-rank tests as appropriate, depending on the distribution of the data as determined by a Shapiro-Wilk test. Difference in signal-to-noise ratio in the liver between LAFOV PET/CT and reference PET/CT will be assessed using a paired samples t-test or a Wilcoxon signed-rank test as appropriate, depending on the distribution of the data as determined by a Shapiro-Wilk test.The baseline characteristics (e.g., age, length, BMI, etc.) of all included patients will be analysed using descriptive statistics (e.g., mean and standard deviation, etc.).

Countries

Netherlands

Contacts

Public ContactF.A. Verburg

Erasmus MC, Universitair Medisch Centrum Rotterdam

imaging.trialbureau@erasmusmc.nl0107033612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026