Clinical Application of the J-PET Scanner Prototype

NCT ID: NCT06242119

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-07
• Study Completion Date: 2025-10-30

Brief Summary

Positron emission tomography (PET), an advanced diagnostic imaging technique, exploits the annihilation of positrons (e+) to delineate pathological alterations within diseased tissues. Integral to PET scanners are detector systems that transform gamma photons into fluorescent photons, thereby gleaning insights into the energy, time, and spatial distribution of gamma photons emanating from positron-emitting radiopharmaceuticals. Conventional PET scanners, bear a significant financial burden primarily due to their reliance on LSO (lutetium oxyorthosilicate) or LYSO (lutetium yttrium oxyorthosilicate) scintillation crystals. The exorbitant cost and limited availability of these crystal scintillators impede the widespread adoption of PET scanners. In a departure from conventional PET technology, the prototype J-PET scanner employed in this trial employs plastic scintillators, characterized by unique physical properties. This prototype is further equipped with bespoke software enabling three-photon imaging based on the annihilation of ortho-positronium (o-Ps) generated within diseased tissue. This study delves into the clinical applicability of PET scanners employing plastic scintillators, particularly investigating the feasibility of PET imaging using plastic scintillators where gamma quanta interact by mechanisms other than the photoelectric effect. Furthermore, this study endeavors to contemporaneously acquire and analyze data related to the lifetime of ortho-positronium (o-P) atoms emanating from routine radiopharmaceuticals. Additionally, it seeks to validate the utilization of a novel diagnostic indicator, termed the "positron biomarker," through a prospective study, comparing its efficacy to conventional diagnostic PET scanning methodologies.

Detailed Description

Positron emission tomography (PET) is currently one of the basic techniques enabling molecular imaging. This concept means imaging at the level of biochemical processes. 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.

Current PET cameras possess remarkable sensitivity, enabling the detection of changes in chemical concentration as subtle as 1E-11 moles. This unprecedented sensitivity allows for the visualization of metabolic alterations, neurotransmitter imbalances, or receptor system dysfunctions at an early stage, often before the onset of clinical symptoms in various diseases. The PET technique relies on radioisotopes that emit positrons, which are the antimatter counterparts of electrons. PET cameras, tasked with monitoring positron distribution, employ detector systems that capture the radiation generated during positron-electron annihilation. This annihilation process occurs in the emission of gamma ray photons, which are detected by the appropriate detector arrays. The computer system particularly records only those events that simultaneously trigger two detectors, ensuring high spatial resolution and precise anatomical localization of the annihilation events. Notably, positron annihilation may be preceded by the formation of positronium, a transient, quasi-stable bound state comprising an electron and its antiparticle, the positron. Due to the mutual arrangement of spins, two states of the positron are distinguished.

• When the electron and positron spins are parallel (triplet state ↑↑); this arrangement is called ortho-positronium (o-Ps). o-Ps decays (annihilation occurs) after an average vacuum lifetime of 142 nanoseconds [ns]. Annihilation produces three gamma ray photons.
• When the spins of the electron and positron are antiparallel (singlet state ↑↓) - the system is called para-positronium (p-Ps). Annihilation produces two gamma-ray photons with an average vacuum lifetime of 125 picoseconds [ps], or 1,136 times shorter.

Distinct from conventional PET scanners employed in diagnostic imaging, the J-PET scanner boasts three remarkable features:

1. Plastic Scintillation: unlike standard PET scanners that use expensive scintillation crystals, the J-PET scanner utilizes plastic scintillators, significantly lowering its cost and making it more affordable.

2. Modular Design: J-PET's modular design allows for easy customization to fit different patient sizes and can be expanded to a whole-body PET scanner. This flexibility caters to a wide range of patient populations and diagnostic needs.

3. Positronium Biomarker: J-PET expands the scope of PET imaging by introducing the detection and analysis of o-Ps.

Ad. 1. Conventional PET scanners use crystal detectors that detect gamma rays using the photoelectric effect. More expensive PET scanners use LSO, LYSO, or BGO crystals. New PET scanners use plastic detectors that detect gamma rays using Compton scattering. This allows for cheaper scanners with the same or better image quality.

Ad. 2. Thanks to the modular design and the use of strip scintillators, the time-of-flight (ToF) parameter is also used to improve image quality or obtain images of the same quality in a shorter examination because it reduces noise.

Ad.3. This capability opens up the possibility of utilizing a novel diagnostic biomarker that holds promising potential but remains underexplored in PET technology. Positronium imaging is applied only in the J-PET scanner. The PET technique uses radioisotopes that emit positron radiation (beta+). Traditional PET scanners image the distribution of gamma ray photons produced by the annihilation of an electron (e-) and a positron (e+). Annihilation may be preceded by the appearance of a positronium atom, which occurs in approximately 30-40% of all annihilations occurring in the patient body.

Working hypothesis:

The J-PET scanner is based on technology using plastic scintillators. If its clinical usefulness is proven, the development of this imaging method may significantly reduce the costs and increase the availability of PET/CT imaging.

Moreover, the J-PET tomograph allows us to determine a new diagnostic indicator, which is the lifetime of positronium atoms.

Aim of the study:

This study aims to demonstrate the clinical feasibility of PET scanners based on plastic scintillators, specifically investigating the performance of three-photon imaging and the use of positronium as a diagnostic biomarker. If the J-PET method allows to record the distribution of a chemical substance acting as a radiopharmaceutical with greater accuracy and - independently, it is possible to record the o-Ps lifetime depending on the biochemical composition of the environment, which is an additional parameter - not yet used in medical imaging.

Conditions

Prostate Cancer; Prostatic Hyperplasia; Prostatic Neoplasms; Prostate Cancer Metastatic; Neuroendocrine Tumors; Neuroendocrine Carcinoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

J-PET scan

Intervention Type: DIAGNOSTIC_TEST

Diagnostic Test: Positron-Emission Tomography Imaging Examination of radiation distribution in the patient 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, \[18F\]choline or \[68Ga\]Ga-DOTATATE). The duration of the additional exam will be approximately 20 minutes.

Interventions

J-PET scan

Diagnostic Test: Positron-Emission Tomography Imaging Examination of radiation distribution in the patient 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, \[18F\]choline or \[68Ga\]Ga-DOTATATE). The duration of the additional exam will be approximately 20 minutes.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• The patient is referred for a PET/CT scan, in accordance with recognized indications for examining 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
• Lack of informed consent to participate in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital in Krakow

OTHER

Sponsor Role: collaborator

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Ewa Stępień, PhD

Head of Department of Medical Physics, Institute of Physics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marta Opalinska, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology and Nuclear Medicine, University Hospital in Krakow

Pawel Moskal, PhD

Role: STUDY_CHAIR

Jagiellonian University

Ewa Stepien, PhD

Role: STUDY_DIRECTOR

Jagiellonian University

Locations

Department of Endocrinology and Nuclear Medicine, University Hospital in Krakow

Krakow, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Pawel Moskal, PhD

Role: CONTACT

p.moskal@uj.edu.pl

800-555-5555 ext. +48-126644558

Ewa Stepien, PhD

Role: CONTACT

e.stepien@uj.edu.pl

800-555-5555 ext. +48-126644762

Facility Contacts

Marta Opalinska, MD, PhD

Role: primary

marta.opalinska@uj.edu.pl

+48124001455

Boguslaw Glowa, MD, PhD

Role: backup

glowa@su.krakow.pl

+48124001468

References

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.

Reference Type: BACKGROUND

PMID: 34644101 (View on PubMed)

Moskal 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.

Reference Type: BACKGROUND

PMID: 32739047 (View on PubMed)

Moskal 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.

Reference Type: BACKGROUND

PMID: 36959477 (View on PubMed)

Dadgar 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.

Reference Type: BACKGROUND

PMID: 37819578 (View on PubMed)

Moskal 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.

Reference Type: BACKGROUND

PMID: 30641509 (View on PubMed)

Huang B, Li T, Arino-Estrada G, Dulski K, Shopa RY, Moskal P, Stepien E, Qi J. SPLIT: Statistical Positronium Lifetime Image Reconstruction via Time-Thresholding. IEEE Trans Med Imaging. 2024 Jun;43(6):2148-2158. doi: 10.1109/TMI.2024.3357659. Epub 2024 Jun 3.

Reference Type: BACKGROUND

PMID: 38261489 (View on PubMed)

Related Links

https://patents.google.com/patent/US8859973B2/en?oq=US+8%2c859%2c973

Description Patent US8859973B2: Strip device and method for determining the location and time of reaction of the gamma quanta and the use of the device to determine the location and time of reaction of the gamma quanta in positron emission tomography

https://ieeexplore.ieee.org/document/9059856

P. Moskal, "Positronium Imaging," 2019 IEEE Nuclear Science Symposium and Medical Imaging Conference (NSS/MIC), Manchester, UK, 2019, pp. 1-3

https://patents.google.com/patent/US9804274B2/en?q=(positronium)&inventor=moskal&oq=moskal+positronium

Description Patent US9804274B2:Hybrid TOF-PET/CT tomograph comprising polymer strips made of scintillator material

Other Identifiers

MO 01.08.2023 J-PET

Identifier Type: -

Identifier Source: org_study_id