Trial Title:
Clinical Application of the J-PET Scanner Prototype
NCT ID:
NCT06242119
Condition:
Prostate Cancer
Prostatic Hyperplasia
Prostatic Neoplasms
Prostate Cancer Metastatic
Neuroendocrine Tumors
Neuroendocrine Carcinoma
Conditions: Official terms:
Prostatic Neoplasms
Neuroendocrine Tumors
Carcinoma, Neuroendocrine
Prostatic Hyperplasia
Hyperplasia
Conditions: Keywords:
positronium
PET
[18F]FDG
[18F]choline
[68Ga]Ga-DOTA-TATE
[68Ga]Ga-PSMA
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
J-PET scan
Description:
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.
Arm group label:
J-PET group
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Endocrinology and Nuclear Medicine, University Hospital in Krakow
Address:
City:
Krakow
Zip:
31-501
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Marta Opalinska, MD, PhD
Phone:
+48124001455
Email:
marta.opalinska@uj.edu.pl
Contact backup:
Last name:
Boguslaw Glowa, MD, PhD
Phone:
+48124001468
Email:
glowa@su.krakow.pl
Investigator:
Last name:
Anna Sowa-Staszczak, MD, PhD
Email:
Principal Investigator
Start date:
March 7, 2024
Completion date:
October 14, 2024
Lead sponsor:
Agency:
Jagiellonian University
Agency class:
Other
Collaborator:
Agency:
University Hospital in Krakow
Agency class:
Other
Source:
Jagiellonian University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06242119
https://patents.google.com/patent/US8859973B2/en?oq=US+8%2c859%2c973
https://ieeexplore.ieee.org/document/9059856
https://patents.google.com/patent/US9804274B2/en?q=(positronium)&inventor=moskal&oq=moskal+positronium
