Neurodegenerative DiseasesJPETClinicNCT06211803
Clinical Application of the Prototype J-PET Device
An observational study of Neurodegenerative Diseases and Brain Neoplasms, run by Jagiellonian University at 1 site in Poland.
Trial summary
Positron emission tomography (PET) is a diagnostic imaging technique that uses positron emission (e-) to image changes in diagnosed tissues. Detector systems are an important part of PET scanners. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurodegenerative Diseases, Brain Neoplasms, Neuroendocrine Tumors
- What is being tested?
- Positron-Emission Tomography Imaging
- How many people
- 10 participants
- Where
- 1 sitePoland
- Study dates
- 11 Mar 2022to 22 Mar 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The research group in this study consisted of patients who were diagnosed at the Department of Nuclear Medicine of the Medical University of Warsaw. Patients underwent routine diagnostic positron emission tomography (PET) examination to diagnose diseases of the central nervous system (CNS). Patient characteristics: Patients were over 18 years of age. They were of Polish origin, white. The patients represented a variety of CNS disorders, including: Brain tumors, such as glial tumors, solid tumors and primary tumors of the nervous system, Neurodegenerative diseases, Neuroendocrine tumors.
Who may be able to join
- The patient is referred for a PET/CT scan, in accordance with recognized indications for examining the brain or the entire body.
- Age over 18 years
- Informed, voluntary consent to participate in the study
Who cannot join
- Pregnant women, breastfeeding women
- People with a previously diagnosed allergy to radiopharmaceuticals
- age under 18 years
- Lack of cooperation with the patient
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Nuclear Medicine
Warsaw, Masovian Voivodeship, 02-092
About this study
Positron emission tomography (PET) is a diagnostic imaging technique that uses positron emission (e-) to image changes in diagnosed tissues. Detector systems are an important part of PET scanners. They can convert gamma photons into fluorescent photons to obtain information about energy, time and position, of the gamma photons obtained through the use of an appropriate positron-emitting radiopharmaceutical. Conventional PET scanners are expensive mostly because they require the use of LSO (lutetium oxyorthosilicate) or LYSO (lutetium yttrium oxyorthosilicate) scintillation crystals. Such crystal scintillators are very costly and difficult to obtain, which limits accessibility of the PET- scanners. The prototype J-PET scanner tested in this trial uses plastic scintillators in which different physical phenomena occur compared to crystal scintillators. In addition, the J-PET scanner prototype is equipped with unique software enabling three-photon imaging, based on the annihilation resulting from the formation of the orto-positronium (o-Ps) in diagnosed tissue. The aim of this study is to demonstrate the clinical acceptability of such scanners based on plastic scintillators, which can additionally collect and process information on the lifetime of o-Ps derived from routinely used radiopharmaceuticals. Additionally, the aim of this study is to demonstrate the use of the new diagnostic indicator "positronium biomarker" in a prospective study, compared to routine diagnostic scanning.
Read the detailed description
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.
The J-PET scanner, unlike PET scanners commonly used in diagnostics, has three important features:
- J-PET scintillators are made of plastic instead of expensive-to-produce LSO (lutetium oxyorthosilicate) or LYSO (lutetium yttrium oxyorthosilicate) scintillation crystals use in regular PET scanners;
- J-PET is modular and can be adapted to the patient's size and expanded to a total-body PET scanner because;
- J-PET can be used to test an additional parameter called the "positronium biomarker" which has not been used so far.
Ad. 1. Conventional PET scanners use LSO or LYSO scintillation crystals, which exploit the photoelectric effect and convert gamma photons into fluorescent photons to obtain information on the energy, time and position of gamma photons emitted by the positron annihilation (e+) process obtained by using an appropriate e+ emitting radiopharmaceutical. In plastic scintillators used in J-PET, the Compton effect is used, i.e. the phenomenon of scattering of high-energy photons on free or weakly bound electrons of the scintillator.
Ad. 2. The modular J-PET scanner can also be easily integrated with existing computed tomography (CT) systems, allowing for simultaneous conduction of both types of examinations.
Ad. 3. Positronium imaging is applied 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 positron atom - a quasi-stable system composed of an electron (e-) and its antiparticle - positron (e+), which occurs in approximately 30-40% of all annihilations occurring in the patient's body.
The time of such annihilation taking place through the state of the positronium atom depends on whether a positronium will be created in which e- and e+ will have parallel spins (triplet state ↑↑, this system is called ortho-positronium - o-Ps) or antiparallel spins (state singlet ↑ ↓, this system is called para-positronium - p-Ps). The average life time of o-Ps in vacuum is more then 1000 times longer (142 nano-seconds [ns]), then the average life time of p-Ps (125 pico-seconds [ps]). The average lifetime of o-Ps in a vacuum is over 1000 times longer (142 nanoseconds [ns]) than the average lifetime of p-Ps (125 picoseconds [ps]). The second difference is that o-Ps annihilation takes place over 3 photons, which has not been detected so far and which traditional PET. the annihilation time of the o-Ps atom can be an additional diagnostic parameter ("positronium biomarker") to be measured and analyzed in the J-PET scanner.
The clinical application of such "positronium biomarker" in terms of lesion detection, image quality and quantification is yet to be determined, which this study aims to address.
- Being tested
- Positron-Emission Tomography Imaging
- Keywords
- PSMA, PET, FDG, DOTATATE, positronium, Somatostatin analogues
- Medical subject headings
- Neurodegenerative Diseases, Brain Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron-Emission Tomography ImagingDiagnostic test
Also called PET Imaging, PET Scan, Positron-Emission Tomography
Examination of radiation distribution in the patient brain and 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 or [68Ga]Ga-DOTATATE). The duration of the additional exam will be approximately 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Positron-Emission Tomography Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the quality of tests performed using J-PET prototype
The reference result for the J-PET test will be the result obtained using a PET/CT device owned by the Department of Nuclear Medicine of the Medical University of Warsaw. For this purpose, the test images obtained with the two cameras will be analyzed by a team of medical physicists (phantom tests) and doctors, according to the principles given above.
Measured: Initial analyzes will last 12 weeks
Secondary outcomes (1)
Analysis of positronium duration in the disease focus and reference area
The lifetime of positronium is a parameter characterizing the examined structures, including the structures of brain tissues. The J-PET group proposed the use of positronium lifetime as a new diagnostic biomarker. There are currently no similar studies in the literature.
Measured: It is planned that the first results will be obtained after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start11 Mar 2022
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Warsaw
- Responsible party
- Principal investigator, Ewa Stępień, PhD, Jagiellonian University
- Investigators
- Leszek Krolicki, MD, PhD, Study chair, Medical University of WarsawEwa L Stepien, PhD, Study director, Jagiellonian UniversityPawel Moskal, PhD, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211803
- Sponsor's protocol ID
- KB16/2022
- Other IDs
- TEAM POIR.04.04.00-00-4204/17, 2021/42/A/ST2/00423, 2021/43/B/ST2/02150;, SPUB/SP/490528/2021, CRP/0641.221.2020
- Acronym
- JPETClinic
- Status last verified
- Jan 2024
- First submitted
- 28 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34644101Moskal 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.
PubMed 32739047Moskal 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.
PubMed 36959477Dadgar 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.
PubMed 37819578Moskal 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.
PubMed 30641509
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of the Prototype J-PET Device
- ClinicalTrials.gov ID
- NCT06211803
- Acronym / sponsor ID
- JPETClinic / KB16/2022
- Keywords
- PSMA, PET, FDG, DOTATATE, positronium, Somatostatin analogues
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Collaborators
- Medical University of Warsaw
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Positron emission tomography (PET) is a diagnostic imaging technique that uses positron emission (e-) to image changes in diagnosed tissues. Detector systems are an important part of PET scanners. They can convert gamma photons into fluorescent photons to obtain information about energy, time and position, of the gamma photons obtained through the use of an appropriate positron-emitting radiopharmaceutical. Conventional PET scanners are expensive mostly because they require the use of LSO (lutetium oxyorthosilicate) or LYSO (lutetium yttrium oxyorthosilicate) scintillation crystals. Such crystal scintillators are very costly and difficult to obtain, which limits accessibility of the PET- scanners. The prototype J-PET scanner tested in this trial uses plastic scintillators in which different physical phenomena occur compared to crystal scintillators. In addition, the J-PET scanner prototype is equipped with unique software enabling three-photon imaging, based on the annihilation resulting from the formation of the orto-positronium (o-Ps) in diagnosed tissue. The aim of this study is to demonstrate the clinical acceptability of such scanners based on plastic scintillators, which can additionally collect and process information on the lifetime of o-Ps derived from routinely used radiopharmaceuticals. Additionally, the aim of this study is to demonstrate the use of the new diagnostic indicator "positronium biomarker" in a prospective study, compared to routine diagnostic scanning.
Detailed description
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.
The J-PET scanner, unlike PET scanners commonly used in diagnostics, has three important features:
- J-PET scintillators are made of plastic instead of expensive-to-produce LSO (lutetium oxyorthosilicate) or LYSO (lutetium yttrium oxyorthosilicate) scintillation crystals use in regular PET scanners;
- J-PET is modular and can be adapted to the patient's size and expanded to a total-body PET scanner because;
- J-PET can be used to test an additional parameter called the "positronium biomarker" which has not been used so far.
Ad. 1. Conventional PET scanners use LSO or LYSO scintillation crystals, which exploit the photoelectric effect and convert gamma photons into fluorescent photons to obtain information on the energy, time and position of gamma photons emitted by the positron annihilation (e+) process obtained by using an appropriate e+ emitting radiopharmaceutical. In plastic scintillators used in J-PET, the Compton effect is used, i.e. the phenomenon of scattering of high-energy photons on free or weakly bound electrons of the scintillator.
Ad. 2. The modular J-PET scanner can also be easily integrated with existing computed tomography (CT) systems, allowing for simultaneous conduction of both types of examinations.
Ad. 3. Positronium imaging is applied 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 positron atom - a quasi-stable system composed of an electron (e-) and its antiparticle - positron (e+), which occurs in approximately 30-40% of all annihilations occurring in the patient's body.
The time of such annihilation taking place through the state of the positronium atom depends on whether a positronium will be created in which e- and e+ will have parallel spins (triplet state ↑↑, this system is called ortho-positronium - o-Ps) or antiparallel spins (state singlet ↑ ↓, this system is called para-positronium - p-Ps). The average life time of o-Ps in vacuum is more then 1000 times longer (142 nano-seconds [ns]), then the average life time of p-Ps (125 pico-seconds [ps]). The average lifetime of o-Ps in a vacuum is over 1000 times longer (142 nanoseconds [ns]) than the average lifetime of p-Ps (125 picoseconds [ps]). The second difference is that o-Ps annihilation takes place over 3 photons, which has not been detected so far and which traditional PET. the annihilation time of the o-Ps atom can be an additional diagnostic parameter ("positronium biomarker") to be measured and analyzed in the J-PET scanner.
The clinical application of such "positronium biomarker" in terms of lesion detection, image quality and quantification is yet to be determined, which this study aims to address.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| J-PET group | – | Diagnostic Test: Positron-Emission Tomography ImagingThe patient is referred for a PET/CT scan, in accordance with recognized indications for examining the brain or the entire body. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The research group in this study consisted of patients who were diagnosed at the Department of Nuclear Medicine of the Medical University of Warsaw. Patients underwent routine diagnostic positron emission tomography (PET) examination to diagnose diseases of the central nervous system (CNS). Patient characteristics: Patients were over 18 years of age. They were of Polish origin, white. The patients represented a variety of CNS disorders, including: Brain tumors, such as glial tumors, solid tumors and primary tumors of the nervous system, Neurodegenerative diseases, Neuroendocrine tumors.
Key inclusion criteria (3 listed)
- The patient is referred for a PET/CT scan, in accordance with recognized indications for examining the brain or the entire body.
- Age over 18 years
- Informed, voluntary consent to participate in the study
Key exclusion criteria (4 listed)
- Pregnant women, breastfeeding women
- People with a previously diagnosed allergy to radiopharmaceuticals
- age under 18 years
- Lack of cooperation with the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron-Emission Tomography ImagingAlso: PET Imaging, PET Scan, Positron-Emission TomographyExamination of radiation distribution in the patient brain and 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 or [68Ga]Ga-DOTATATE). The duration of the additional exam will be approximately 20 minutes. | Diagnostic test | J-PET group |
Primary outcome
Assessment of the quality of tests performed using J-PET prototype
Time frame: Initial analyzes will last 12 weeks
The reference result for the J-PET test will be the result obtained using a PET/CT device owned by the Department of Nuclear Medicine of the Medical University of Warsaw. For this purpose, the test images obtained with the two cameras will be analyzed by a team of medical physicists (phantom tests) and doctors, according to the principles given above.
1 secondary outcome
Analysis of positronium duration in the disease focus and reference area
Time frame: It is planned that the first results will be obtained after 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Background: PubMed 34644101Moskal 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.
- Background: PubMed 32739047Moskal 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.
- Background: PubMed 36959477Moskal 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.
- Background: PubMed 37819578Dadgar 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.
- Background: PubMed 30641509Moskal 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.
- 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 tomographyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Neurodegenerative Diseases
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Not yet recruiting
Comparative Effects of Virtual Reality and Proprioceptive Neuromuscular Facilitation in Patients With Parkinson's Disease
Parkinson Disease
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruiting
Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia
Friedreich Ataxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leszek Krolicki, MD, PhD study chair
Medical University of Warsaw
Ewa L Stepien, PhD study director
Jagiellonian University
Pawel Moskal, PhD principal investigator
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodegenerative Diseases and Brain Neoplasms, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the quality of tests performed using J-PET prototype (time frame: Initial analyzes will last 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06211803, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.