Clinical Application of the Prototype J-PET Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-11

Study Completion Date

2022-03-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Application of the J-PET Scanner Prototype

NCT06242119

Prostate Cancer Prostatic Hyperplasia Prostatic Neoplasms +3 more

RECRUITING

Positron Emission Tomography/Magnetic Resonance Imaging in Patients

NCT01557881

Colon Cancer Head and Neck Cancer Lung Cancer +5 more

TERMINATED NA

PET and/or MRI Scans in Assessing Tumor Response in Patients Receiving Antiangiogenesis Therapy

NCT00019565

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy

NCT06976021

Triple Negative Breast Cancer Uterine Cervical Cancer Uterine Corpus Cancer +2 more

NOT_YET_RECRUITING PHASE2

Imaging and Plan Workflow in a Novel Low-Field Magnetic Resonance Imaging (MRI) Radiotherapy Device

NCT02331381

Cancer Malignant Tumor

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. 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;
2. J-PET is modular and can be adapted to the patient's size and expanded to a total-body PET scanner because;
3. 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.

Ad. 3. Positronium imaging is applied 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 positron atom - a quasi-stable system composed of an electron (e-) and its antiparticle - positron (e+), which occurs in approximately 30-40% of all annihilations occurring in the patient's body.

The time of such annihilation taking place through the state of the positronium atom depends on whether a positronium will be created in which e- and e+ will have parallel spins (triplet state ↑↑, this system is called ortho-positronium - o-Ps) or antiparallel spins (state singlet ↑ ↓, this system is called para-positronium - p-Ps). The average life time of o-Ps in vacuum is more then 1000 times longer (142 nano-seconds \[ns\]), then the average life time of p-Ps (125 pico-seconds \[ps\]). The average lifetime of o-Ps in a vacuum is over 1000 times longer (142 nanoseconds \[ns\]) than the average lifetime of p-Ps (125 picoseconds \[ps\]). The second difference is that o-Ps annihilation takes place over 3 photons, which has not been detected so far and which traditional PET. the annihilation time of the o-Ps atom can be an additional diagnostic parameter ("positronium biomarker") to be measured and analyzed in the J-PET scanner.

The clinical application of such "positronium biomarker" in terms of lesion detection, image quality and quantification is yet to be determined, which this study aims to address.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurodegenerative Diseases Brain Neoplasms Neuroendocrine Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Positron-Emission Tomography Imaging

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Positron-Emission Tomography Imaging

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PET Imaging PET Scan Positron-Emission Tomography

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ewa Stępień, PhD

Head of Department of Medical Physics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Leszek Krolicki, MD, PhD

Role: STUDY_CHAIR

Medical University of Warsaw

Ewa L Stepien, PhD

Role: STUDY_DIRECTOR

Jagiellonian University

Pawel Moskal, PhD

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Nuclear Medicine

Warsaw, Masovian Voivodeship, Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

References

Explore related publications, articles, or registry entries linked to this study.

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)