Clinical Application of the Prototype J-PET Device
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Assessment of the quality of tests performed using J-PET prototype
Study Overview
Brief Summary
Positron emission tomography (PET) is a diagnostic imaging technique that uses positron emission (e-) to image changes in diagnosed tissues. Detector systems are an important part of PET scanners. They can convert gamma photons into fluorescent photons to obtain information about energy, time and position, of the gamma photons obtained through the use of an appropriate positron-emitting radiopharmaceutical. Conventional PET scanners are expensive mostly because they require the use of LSO (lutetium oxyorthosilicate) or LYSO (lutetium yttrium oxyorthosilicate) scintillation crystals. Such crystal scintillators are very costly and difficult to obtain, which limits accessibility of the PET- scanners. The prototype J-PET scanner tested in this trial uses plastic scintillators in which different physical phenomena occur compared to crystal scintillators. In addition, the J-PET scanner prototype is equipped with unique software enabling three-photon imaging, based on the annihilation resulting from the formation of the orto-positronium (o-Ps) in diagnosed tissue. The aim of this study is to demonstrate the clinical acceptability of such scanners based on plastic scintillators, which can additionally collect and process information on the lifetime of o-Ps derived from routinely used radiopharmaceuticals. Additionally, the aim of this study is to demonstrate the use of the new diagnostic indicator "positronium biomarker" in a prospective study, compared to routine diagnostic scanning.
Detailed Description
The J-PET scanner is the world's first positron tomograph based on plastic strip scintillators to measure the lifetime of the ortho-positronium (o-Ps) atom. This is a modular scanner, designed and installed at the Department of Experimental Particle Physics and Applications of the Jagiellonian University in Krakow. The J-PET scanner is based on technology patented in 2014 and 2016.
The J-PET scanner, unlike PET scanners commonly used in diagnostics, has three important features:
- J-PET scintillators are made of plastic instead of expensive-to-produce LSO (lutetium oxyorthosilicate) or LYSO (lutetium yttrium oxyorthosilicate) scintillation crystals use in regular PET scanners;
- J-PET is modular and can be adapted to the patient's size and expanded to a total-body PET scanner because;
- J-PET can be used to test an additional parameter called the "positronium biomarker" which has not been used so far.
Ad. 1. Conventional PET scanners use LSO or LYSO scintillation crystals, which exploit the photoelectric effect and convert gamma photons into fluorescent photons to obtain information on the energy, time and position of gamma photons emitted by the positron annihilation (e+) process obtained by using an appropriate e+ emitting radiopharmaceutical. In plastic scintillators used in J-PET, the Compton effect is used, i.e. the phenomenon of scattering of high-energy photons on free or weakly bound electrons of the scintillator.
Ad. 2. The modular J-PET scanner can also be easily integrated with existing computed tomography (CT) systems, allowing for simultaneous conduction of both types of examinations.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patient is referred for a PET/CT scan, in accordance with recognized indications for examining the brain or the entire body.
- •Age over 18 years
- •Informed, voluntary consent to participate in the study
Exclusion Criteria
- •Pregnant women, breastfeeding women
- •People with a previously diagnosed allergy to radiopharmaceuticals
- •age under 18 years
- •Lack of cooperation with the patient
Outcomes
Primary Outcomes
Assessment of the quality of tests performed using J-PET prototype
Time Frame: Initial analyzes will last 12 weeks
The reference result for the J-PET test will be the result obtained using a PET/CT device owned by the Department of Nuclear Medicine of the Medical University of Warsaw. For this purpose, the test images obtained with the two cameras will be analyzed by a team of medical physicists (phantom tests) and doctors, according to the principles given above.
Secondary Outcomes
- Analysis of positronium duration in the disease focus and reference area(It is planned that the first results will be obtained after 6 months.)
Investigators
Ewa Stępień, PhD
Head of Department of Medical Physics
Jagiellonian University