Skip to main content
OpenTrials
Completed

NCT Number: NCT05496920

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inselspital, Universitätsspital Bern

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FD-PET/CT

Diagnostic Test

Standard of care PET/CT with full dose (FD) of the radiopharmaceutical

LD-PET/CT

Diagnostic Test

Additional low dose PET/CT performed within protocol defined time frame LD-PET/CT with additional ultra-low dose CT-less reconstruction

Primary outcomes

  1. Intra-rater correlation coefficient

    Time frame: 2-6 weeks following scan

    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

Secondary outcomes

  1. Intra-rater correlation coefficient

    Time frame: 2-6 weeks following scan

    ICC for ultra-low dose (ULD)-PET/CT compared to FD- and LD-PET/CT

  2. Lesion uptake

    Time frame: 2-6 weeks following scan

    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

  3. Image quality

    Time frame: 2-6 weeks following scan

    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

  4. Subjective quality

    Time frame: 2-6 weeks following scan

    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

  5. Agreement

    Time frame: 2-6 weeks following scan

    Inter-reader agreement for the primary outcome (UICC cancer stage) shall be compared between LD and FD-PET/CT

  6. Diagnostic accuracy

    Time frame: 2-6 weeks following scan

    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

Other outcomes

  1. Acceptability

    Time frame: 2-6 weeks following scan

    Additional outcome of interest: Patient and referrer acceptability of low-dose PET/CT examinations examined by means of a structured questionnaire.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study 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

Acronym: ULD-PET

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 11, 2022
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.