Prostate CancerJPET2ClinicNCT06242119
Clinical Application of the J-PET Scanner Prototype
An observational study of Prostate Cancer and Prostatic Hyperplasia, run by Jagiellonian University at 1 site in Poland.
Trial summary
Positron emission tomography (PET), an advanced diagnostic imaging technique, exploits the annihilation of positrons (e+) to delineate pathological alterations within diseased tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Prostatic Hyperplasia, Prostatic Neoplasms
- What is being tested?
- J-PET scan
- How many people
- 25 participants
- Where
- 1 sitePoland
- Study dates
- 7 Mar 2024to 30 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study group will include a maximum of 25 patients aged > 18 years referred for PET/CT examination using [68Ga]Ga-DOTA-TATE or [68Ga]Ga-PSMA or [18F]FDG or [18F ]choline in accordance with recognized oncological clinical indications to the Department of Nuclear Medicine, O/K Department of Endocrinology, Oncological Endocrinology and Nuclear Medicine of the University Hospital in Krakow, who give informed consent to participate in the study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Endocrinology and Nuclear Medicine, University Hospital in Krakow
Krakow, 31-501
Marta Opalinska, MD, PhD, +48124001455, marta.opalinska@uj.edu.pl
Boguslaw Glowa, MD, PhD, +48124001468, glowa@su.krakow.pl
About this study
Official title: Clinical Use of a J-PET Scanner Prototype Made of Plastic Scintilators
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.
Read the 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:
- 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.
- 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.
- 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
- Being tested
- J-PET scan
- Keywords
- positronium, PET, [18F]FDG, [18F]choline, [68Ga]Ga-DOTA-TATE, [68Ga]Ga-PSMA
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia, Neuroendocrine Tumors, Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J-PET scanDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: J-PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraclass correlation coefficient (ICC)
ICC for Cancer Stage using the union for international cancer control (UICC) TNM (T= tumor, N= nodal stage, M = metastasis) System (8th Edition) for plastic scanner positron emission and computed tomography (J-PET/CT) exams compared to the standard of care (SOC) full-dose PET/CT as assessed by a panel of physicians
Measured: Initial analyzes will last 12 weeks
Secondary outcomes (4)
Image quality
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 J-PET/CT compared to the standard of care PET/CT
Measured: after 3 months following scan
Subjective quality
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 J-PET/CT compared to the standard of care PET/CT
Measured: after 3 months following scan
Agreement
Inter-reader agreement for the primary outcome (UICC cancer stage) shall be compared between J-PET/CT and the standard of care PET/CT
Measured: after 3 months following scan
Diagnostic accuracy
Assessment of the positive predictive value (PPV) for J-PET/CT compared to the standard of care PET/CT for patients who undergo surgery or biopsy and where histopathological confirmation of true positive (TP) and false positive (FP) findings are available
Measured: after 6 months following scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start7 Mar 2024
- Primary completion31 Aug 2024
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital in Krakow
- Responsible party
- Principal investigator, Ewa Stępień, PhD, Jagiellonian University
- Investigators
- Marta Opalinska, MD, PhD, Principal investigator, Department of Endocrinology and Nuclear Medicine, University Hospital in KrakowPawel Moskal, PhD, Study chair, Jagiellonian UniversityEwa Stepien, PhD, Study director, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242119
- Sponsor's protocol ID
- MO 01.08.2023 J-PET
- Acronym
- JPET2Clinic
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34644101Moskal 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.
PubMed 32739047Moskal 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.
PubMed 36959477Dadgar 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.
PubMed 37819578Moskal 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.
PubMed 30641509Huang 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.
PubMed 38261489
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Use of a J-PET Scanner Prototype Made of Plastic Scintilators
- ClinicalTrials.gov ID
- NCT06242119
- Acronym / sponsor ID
- JPET2Clinic / MO 01.08.2023 J-PET
- Conditions
- Prostate Cancer, Prostatic Hyperplasia, Prostatic Neoplasms, Prostate Cancer Metastatic, Neuroendocrine Tumors, Neuroendocrine Carcinoma
- Keywords
- positronium, PET, [18F]FDG, [18F]choline, [68Ga]Ga-DOTA-TATE, [68Ga]Ga-PSMA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Collaborators
- University Hospital in Krakow
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| J-PET group | – | Diagnostic Test: J-PET scanThe patient is referred for a PET/CT scan, in accordance with recognized indications for examining the brain or the entire body. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study group will include a maximum of 25 patients aged > 18 years referred for PET/CT examination using [68Ga]Ga-DOTA-TATE or [68Ga]Ga-PSMA or [18F]FDG or [18F ]choline in accordance with recognized oncological clinical indications to the Department of Nuclear Medicine, O/K Department of Endocrinology, Oncological Endocrinology and Nuclear Medicine of the University Hospital in Krakow, who give informed consent to participate in the study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| J-PET scanDiagnostic 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. | Diagnostic test | J-PET group |
Primary outcome
Intraclass correlation coefficient (ICC)
Time frame: Initial analyzes will last 12 weeks
ICC for Cancer Stage using the union for international cancer control (UICC) TNM (T= tumor, N= nodal stage, M = metastasis) System (8th Edition) for plastic scanner positron emission and computed tomography (J-PET/CT) exams compared to the standard of care (SOC) full-dose PET/CT as assessed by a panel of physicians
4 secondary outcomes
Image quality
Time frame: after 3 months following scan
Subjective quality
Time frame: after 3 months following scan
Agreement
Time frame: after 3 months following scan
Diagnostic accuracy
Time frame: after 6 months following scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Background: PubMed 34644101Moskal 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.
- Background: PubMed 32739047Moskal 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.
- Background: PubMed 36959477Moskal 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.
- Background: PubMed 37819578Dadgar 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.
- Background: PubMed 30641509Moskal 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.
- Background: PubMed 38261489Huang 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.
- 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 tomographyLink provided by the sponsor.
- P. Moskal, "Positronium Imaging," 2019 IEEE Nuclear Science Symposium and Medical Imaging Conference (NSS/MIC), Manchester, UK, 2019, pp. 1-3Link provided by the sponsor.
- Description Patent US9804274B2:Hybrid TOF-PET/CT tomograph comprising polymer strips made of scintillator materialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Active, not recruitingObservational study
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
Prostate Cancer, Prostatic Neoplasms
Active, not recruitingPhase 2
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Opalinska, MD, PhD principal investigator
Department of Endocrinology and Nuclear Medicine, University Hospital in Krakow
Pawel Moskal, PhD study chair
Jagiellonian University
Ewa Stepien, PhD study director
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostatic Hyperplasia, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pawel Moskal, PhD (800-555-5555 ext. +48-126644558, p.moskal@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraclass correlation coefficient (ICC) (time frame: Initial analyzes will last 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06242119, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.