Clinical Application of the J-PET Scanner Prototype

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJagiellonian University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant women, breastfeeding women

People with a previously diagnosed allergy to radiopharmaceuticals

Age under 18 years

Lack of cooperation with the patient

Trial 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.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: J-PET group1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Initial analyzes will last 12 weeks

Secondary outcomes

1

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

Time frame
after 3 months following scan
2

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

Time frame
after 3 months following scan
3

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

Time frame
after 3 months following scan
4

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

Time frame
after 6 months following scan

Other outcomes

Sponsors and contacts

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Jagiellonian University

Lead sponsor

University Hospital in Krakow

Collaborator