PET/CT Clinical Trial
— ULD-PETOfficial 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
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
Status | Recruiting |
Enrollment | 42 |
Est. completion date | March 31, 2025 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Inselspital, Universitätsspital Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acceptability | Additional outcome of interest: Patient and referrer acceptability of low-dose PET/CT examinations examined by means of a structured questionnaire. | 2-6 weeks following scan | |
Primary | Intra-rater correlation coefficient | ICC for Cancer Stage using the union for international cancer control (UICC) TNM (T= tumor, N= nodal stage, M = metastasis) System (8th Edition) for low dose positron emission and computed tomography (LD-PET/CT) exams compared to the standard of care (SOC) full-dose (FD)-PET/CT as assessed by a panel of physicians | 2-6 weeks following scan | |
Secondary | Intra-rater correlation coefficient | ICC for ultra-low dose (ULD)-PET/CT compared to FD- and LD-PET/CT | 2-6 weeks following scan | |
Secondary | Lesion uptake | Composite outcome assessing lesion quantification in terms of peak standardised uptake value (SUVpeak), tumour to background (TBR), metabolic tumour volume (MTV) and tumour glycolytic activity (TLG) for ULD- and LD-PET/CT compared to the standard of care FD-PET/CT | 2-6 weeks following scan | |
Secondary | Image quality | Composite outcome assessing image quality in terms of tumour to background ratio (TBR) and signal to noise (SNR), defined as the reciprocal coefficient of variation (COV) for ULD- and LD-PET/CT compared to the standard of care FD-PET/CT | 2-6 weeks following scan | |
Secondary | Subjective quality | Image quality (subjective) as rated by five independent nuclear medicine physicians on a five-point Likert scale (1= unacceptable, 2=poor, 3=moderate, 4=good, 5=high) for ULD- and LD-PET/CT compared to the standard of care FD-PET/CT | 2-6 weeks following scan | |
Secondary | Agreement | Inter-reader agreement for the primary outcome (UICC cancer stage) shall be compared between LD and FD-PET/CT | 2-6 weeks following scan | |
Secondary | Diagnostic accuracy | Assessment of the positive predictive value (PPV) for LD- and FD-PET/CT for patients who undergo surgery or bronchoscopy and where histopathological confirmation of true positive (TP) and false positive (FP) findings are available | 2-6 weeks following scan |
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