Clinical Application of the Prototype J-PET Device
JPETClinic
6 other identifiers
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2022
CompletedFirst Submitted
Initial submission to the registry
December 28, 2023
CompletedFirst Posted
Study publicly available on registry
January 18, 2024
CompletedJanuary 18, 2024
January 1, 2024
11 days
December 28, 2023
January 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of the quality of tests performed using J-PET prototype
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.
Initial analyzes will last 12 weeks
Secondary Outcomes (1)
Analysis of positronium duration in the disease focus and reference area
It is planned that the first results will be obtained after 6 months.
Study Arms (1)
J-PET group
The patient is referred for a PET/CT scan, in accordance with recognized indications for examining the brain or the entire body.
Interventions
Examination of radiation distribution in the patient brain and body after completing a routine examination on a PET diagnostic device. J-PET prototype tests will be carried out in patients who have undergone a classic PET examination after administration of \[18F\]FDG), \[68Ga\]Ga-PSMA or \[68Ga\]Ga-DOTATATE). The duration of the additional exam will be approximately 20 minutes.
Eligibility Criteria
The research group in this study consisted of patients who were diagnosed at the Department of Nuclear Medicine of the Medical University of Warsaw. Patients underwent routine diagnostic positron emission tomography (PET) examination to diagnose diseases of the central nervous system (CNS). Patient characteristics: Patients were over 18 years of age. They were of Polish origin, white. The patients represented a variety of CNS disorders, including: Brain tumors, such as glial tumors, solid tumors and primary tumors of the nervous system, Neurodegenerative diseases, Neuroendocrine tumors.
You may qualify if:
- 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
You may not qualify if:
- Pregnant women, breastfeeding women
- People with a previously diagnosed allergy to radiopharmaceuticals
- age under 18 years
- Lack of cooperation with the patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jagiellonian Universitylead
- Medical University of Warsawcollaborator
Study Sites (1)
Department of Nuclear Medicine
Warsaw, Masovian Voivodeship, 02-092, Poland
Related Publications (5)
Moskal P, Dulski K, Chug N, Curceanu C, Czerwinski E, Dadgar M, Gajewski J, Gajos A, Grudzien G, Hiesmayr BC, Kacprzak K, Kaplon L, Karimi H, Klimaszewski K, Korcyl G, Kowalski P, Kozik T, Krawczyk N, Krzemien W, Kubicz E, Malczak P, Niedzwiecki S, Pawlik-Niedzwiecka M, Pedziwiatr M, Raczynski L, Raj J, Rucinski A, Sharma S, Shivani, Shopa RY, Silarski M, Skurzok M, Stepien EL, Szczepanek M, Tayefi F, Wislicki W. Positronium imaging with the novel multiphoton PET scanner. Sci Adv. 2021 Oct 15;7(42):eabh4394. doi: 10.1126/sciadv.abh4394. Epub 2021 Oct 13.
PMID: 34644101BACKGROUNDMoskal P, Stepien EL. Prospects and Clinical Perspectives of Total-Body PET Imaging Using Plastic Scintillators. PET Clin. 2020 Oct;15(4):439-452. doi: 10.1016/j.cpet.2020.06.009. Epub 2020 Jul 29.
PMID: 32739047BACKGROUNDMoskal P, Kubicz E, Grudzien G, Czerwinski E, Dulski K, Leszczynski B, Niedzwiecki S, Stepien EL. Developing a novel positronium biomarker for cardiac myxoma imaging. EJNMMI Phys. 2023 Mar 24;10(1):22. doi: 10.1186/s40658-023-00543-w.
PMID: 36959477BACKGROUNDDadgar M, Parzych S, Baran J, Chug N, Curceanu C, Czerwinski E, Dulski K, Elyan K, Gajos A, Hiesmayr BC, Kaplon L, Klimaszewski K, Konieczka P, Korcyl G, Kozik T, Krzemien W, Kumar D, Niedzwiecki S, Panek D, Perez Del Rio E, Raczynski L, Sharma S, Shivani S, Shopa RY, Skurzok M, Stepien EL, Tayefi Ardebili F, Tayefi Ardebili K, Vandenberghe S, Wislicki W, Moskal P. Comparative studies of the sensitivities of sparse and full geometries of Total-Body PET scanners built from crystals and plastic scintillators. EJNMMI Phys. 2023 Oct 11;10(1):62. doi: 10.1186/s40658-023-00572-5.
PMID: 37819578BACKGROUNDMoskal P, Kisielewska D, Curceanu C, Czerwinski E, Dulski K, Gajos A, Gorgol M, Hiesmayr B, Jasinska B, Kacprzak K, Kaplon L, Korcyl G, Kowalski P, Krzemien W, Kozik T, Kubicz E, Mohammed M, Niedzwiecki S, Palka M, Pawlik-Niedzwiecka M, Raczynski L, Raj J, Sharma S, Shivani, Shopa RY, Silarski M, Skurzok M, Stepien E, Wislicki W, Zgardzinska B. Feasibility study of the positronium imaging with the J-PET tomograph. Phys Med Biol. 2019 Mar 7;64(5):055017. doi: 10.1088/1361-6560/aafe20.
PMID: 30641509BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Leszek Krolicki, MD, PhD
Medical University of Warsaw
- STUDY DIRECTOR
Ewa L Stepien, PhD
Jagiellonian University
- PRINCIPAL INVESTIGATOR
Pawel Moskal, PhD
Jagiellonian University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department of Medical Physics
Study Record Dates
First Submitted
December 28, 2023
First Posted
January 18, 2024
Study Start
March 11, 2022
Primary Completion
March 22, 2022
Study Completion
March 22, 2022
Last Updated
January 18, 2024
Record last verified: 2024-01