Clinical Application of the J-PET Scanner Prototype

NCT06242119 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2025-02-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University Hospital in Krakow

    collaborator OTHER
  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Marta Opalinska, MD, PhD · Department of Endocrinology and Nuclear Medicine, University Hospital in Krakow

  • Pawel Moskal, PhD · Jagiellonian University

  • Ewa Stepien, PhD · Jagiellonian University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2024-08-31
Completion
2025-10-30

Countries

  • Poland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06242119 on ClinicalTrials.gov