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NCT Number: NCT06242119

Clinical Application of the J-PET Scanner Prototype

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Endocrinology and Nuclear Medicine, University Hospital in Krakow

Krakow, 31-501, Poland

Location status: Recruiting

Location contact

Anna Sowa-Staszczak, MD, PhD

PRINCIPAL_INVESTIGATOR

Boguslaw Glowa, MD, PhD

CONTACT

[email protected]

+48124001468

Marta Opalinska, MD, PhD

CONTACT

[email protected]

+48124001455

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

J-PET scan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ewa Stepien, PhD

CONTACT

[email protected]

800-555-5555 ext. +48-126644762

Pawel Moskal, PhD

CONTACT

[email protected]

800-555-5555 ext. +48-126644558

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Collaborators

  • University Hospital in Krakow

Registry information

Official study title

Clinical Use of a J-PET Scanner Prototype Made of Plastic Scintilators

Acronym: JPET2Clinic

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 5, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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