Clinical Application of the J-PET Scanner Prototype

NCT06242119 | Recruiting

• 1 other identifier: MO 01.08.2023 J-PET
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer; Prostatic Hyperplasia; Prostatic Neoplasms; Prostate Cancer Metastatic; Neuroendocrine Tumors; Neuroendocrine Carcinoma

Keywords

positronium; PET; [18F]FDG; [18F]choline; [68Ga]Ga-DOTA-TATE; [68Ga]Ga-PSMA

Outcome Measures

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

  Initial analyzes will last 12 weeks

Secondary Outcomes (4)

• Image quality

  after 3 months following scan

• Subjective quality

  after 3 months following scan

• Agreement

  after 3 months following scan

• Diagnostic accuracy

  after 6 months following scan

Study Arms (1)

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

Interventions

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.

J-PET group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead
• University Hospital in Krakow: collaborator

Study Sites (1)

Department of Endocrinology and Nuclear Medicine, University Hospital in Krakow

Krakow, 31-501, Poland

RECRUITING

Related Publications (6)

• Moskal P, Dulski K, Chug N, Curceanu C, Czerwinski E, Dadgar M, Gajewski J, Gajos A, Grudzien G, Hiesmayr BC, Kacprzak K, Kaplon L, Karimi H, Klimaszewski K, Korcyl G, Kowalski P, Kozik T, Krawczyk N, Krzemien W, Kubicz E, Malczak P, Niedzwiecki S, Pawlik-Niedzwiecka M, Pedziwiatr M, Raczynski L, Raj J, Rucinski A, Sharma S, Shivani, Shopa RY, Silarski M, Skurzok M, Stepien EL, Szczepanek M, Tayefi F, Wislicki W. Positronium imaging with the novel multiphoton PET scanner. Sci Adv. 2021 Oct 15;7(42):eabh4394. doi: 10.1126/sciadv.abh4394. Epub 2021 Oct 13.

  PMID: 34644101 BACKGROUND

• Moskal P, Stepien EL. Prospects and Clinical Perspectives of Total-Body PET Imaging Using Plastic Scintillators. PET Clin. 2020 Oct;15(4):439-452. doi: 10.1016/j.cpet.2020.06.009. Epub 2020 Jul 29.

  PMID: 32739047 BACKGROUND

• Moskal P, Kubicz E, Grudzien G, Czerwinski E, Dulski K, Leszczynski B, Niedzwiecki S, Stepien EL. Developing a novel positronium biomarker for cardiac myxoma imaging. EJNMMI Phys. 2023 Mar 24;10(1):22. doi: 10.1186/s40658-023-00543-w.

  PMID: 36959477 BACKGROUND

• Dadgar M, Parzych S, Baran J, Chug N, Curceanu C, Czerwinski E, Dulski K, Elyan K, Gajos A, Hiesmayr BC, Kaplon L, Klimaszewski K, Konieczka P, Korcyl G, Kozik T, Krzemien W, Kumar D, Niedzwiecki S, Panek D, Perez Del Rio E, Raczynski L, Sharma S, Shivani S, Shopa RY, Skurzok M, Stepien EL, Tayefi Ardebili F, Tayefi Ardebili K, Vandenberghe S, Wislicki W, Moskal P. Comparative studies of the sensitivities of sparse and full geometries of Total-Body PET scanners built from crystals and plastic scintillators. EJNMMI Phys. 2023 Oct 11;10(1):62. doi: 10.1186/s40658-023-00572-5.

  PMID: 37819578 BACKGROUND

• Moskal P, Kisielewska D, Curceanu C, Czerwinski E, Dulski K, Gajos A, Gorgol M, Hiesmayr B, Jasinska B, Kacprzak K, Kaplon L, Korcyl G, Kowalski P, Krzemien W, Kozik T, Kubicz E, Mohammed M, Niedzwiecki S, Palka M, Pawlik-Niedzwiecka M, Raczynski L, Raj J, Sharma S, Shivani, Shopa RY, Silarski M, Skurzok M, Stepien E, Wislicki W, Zgardzinska B. Feasibility study of the positronium imaging with the J-PET tomograph. Phys Med Biol. 2019 Mar 7;64(5):055017. doi: 10.1088/1361-6560/aafe20.

  PMID: 30641509 BACKGROUND

• Huang B, Li T, Arino-Estrada G, Dulski K, Shopa RY, Moskal P, Stepien E, Qi J. SPLIT: Statistical Positronium Lifetime Image Reconstruction via Time-Thresholding. IEEE Trans Med Imaging. 2024 Jun;43(6):2148-2158. doi: 10.1109/TMI.2024.3357659. Epub 2024 Jun 3.

  PMID: 38261489 BACKGROUND

Related Links

• Description Patent US8859973B2: Strip device and method for determining the location and time of reaction of the gamma quanta and the use of the device to determine the location and time of reaction of the gamma quanta in positron emission tomography
• P. Moskal, "Positronium Imaging," 2019 IEEE Nuclear Science Symposium and Medical Imaging Conference (NSS/MIC), Manchester, UK, 2019, pp. 1-3
• Description Patent US9804274B2:Hybrid TOF-PET/CT tomograph comprising polymer strips made of scintillator material

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia; Neuroendocrine Tumors; Carcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Study Officials

• Marta Opalinska, MD, PhD

  Department of Endocrinology and Nuclear Medicine, University Hospital in Krakow

  PRINCIPAL INVESTIGATOR

• Pawel Moskal, PhD

  Jagiellonian University

  STUDY CHAIR

• Ewa Stepien, PhD

  Jagiellonian University

  STUDY DIRECTOR

Central Study Contacts

Pawel Moskal, PhD

CONTACT

800-555-5555; p.moskal@uj.edu.pl

Ewa Stepien, PhD

CONTACT

800-555-5555; e.stepien@uj.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Medical Physics, Institute of Physics

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 5, 2024
• Study Start: March 7, 2024
• Primary Completion: August 31, 2024
• Study Completion: October 30, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

PL (1)