Clinical Application of the J-PET Scanner Prototype (JPET2Clinic)

February 17, 2025 updated by: Ewa Stępień, PhD, Jagiellonian University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pawel Moskal, PhD
  • Phone Number: +48-126644558 800-555-5555
  • Email: p.moskal@uj.edu.pl

Study Contact Backup

Study Locations

  • Poland
      • Krakow, Poland, 31-501
        • Recruiting
        • Department of Endocrinology and Nuclear Medicine, University Hospital in Krakow
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anna Sowa-Staszczak, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Initial analyzes will last 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image quality
Time Frame: after 3 months following scan
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
after 3 months following scan
Subjective quality
Time Frame: after 3 months following scan
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
after 3 months following scan
Agreement
Time Frame: after 3 months following scan
Inter-reader agreement for the primary outcome (UICC cancer stage) shall be compared between J-PET/CT and the standard of care PET/CT
after 3 months following scan
Diagnostic accuracy
Time Frame: after 6 months following scan
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
after 6 months following scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Collaborators

University Hospital in Krakow

Investigators

  • Principal Investigator: Marta Opalinska, MD, PhD, Department of Endocrinology and Nuclear Medicine, University Hospital in Krakow
  • Study Chair: Pawel Moskal, PhD, Jagiellonian University
  • Study Director: Ewa Stepien, PhD, Jagiellonian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

January 27, 2024

First Submitted That Met QC Criteria

January 27, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO 01.08.2023 J-PET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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