Absolute quantification of myocardial blood flow in human subjects with SYN2 dynamic PET imaging
Key facts
- Where
- Kielce és Warsaw, LengyelországSee the 3 sites
- Phase
- 2. fázis
Where in Lengyelország
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w KielcachKielce, LengyelországTaking people
- Affidea Sp. z o.o.Warsaw, LengyelországTaking people
- Wojskowy Instytut Medyczny Panstwowy Instytut BadawczyWarsaw, LengyelországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Synektik S.A.
- Trial code
- EU 2023-507520-23-00
- Record updated
- 2026. március 23.
- Original description
To enable and validate quantitative MBF assessment for SYN2 by establishing the relationship of the basic kinetic SYN2 parameters with the reference flow values from quantitative 13N-ammonia PET MPI dynamic flow studies.Read full original descriptionShow less
To enable and validate quantitative MBF assessment for SYN2 by establishing the relationship of the basic kinetic SYN2 parameters with the reference flow values from quantitative 13N-ammonia PET MPI dynamic flow studies.
Inclusion: The subject must be willing and able to provide signed and dated informed consent form prior to any study related procedures; For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner for 90 days after last IMP exposure; The patient agrees to receive the maximal total radiation dose up to 10 mSv during diagnostic procedures; Agreement to adhere to Lifestyle Considerations (see section 6.4) throughout the study duration; Male or female, over 18 years of age; Patient with CAD suspicion based on symptoms and/or ECG changes as assessed by the referring physician; The patient undergoing a clinically indicated 13N-ammonia PET study within 30 days before informed consenting and not making significant changes in anti-ischemic therapy or undergoing revascularization after 13N-ammonia PET OR the patient is willing to undergo clinically indicated 13N-ammonia and SYN2 study for the purposes of this clinical study; The subject is able and willing to comply with all study procedures as described in the protocol; Must be capable of undergoing the pharmacological (adenosine or regadenoson) stress imaging (PET-CT) protocols; Willingness to abstain sexual intercourse at least 24 hours before and after the tracer administration; For females of reproductive potential: use of sufficiently effective contraception during study participation (from Screening) and for 30 days after the last IMP administration.
Exclusion: Patients enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7-day follow-up period of this study; Female subject has a positive (+) pregnancy test, the possibility of pregnancy cannot be ruled out prior to dosing, or the subject is breast-feeding; Patients who are unable to undergo all the imaging procedures based on the investigator's opinion. Reasons may be any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination; Patients incapable of undergoing pharmacological cardiac stress testing; Patients who have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the patient during cardiac stress testing; Patients undergoing evaluation for heart transplantation or with history of heart transplantation; Known allergy or hypersensitivity for SYN2 components and other acridine derivatives such as Aminacrine, Ethacridine and Euflavine; Known allergy or hypersensitivity for 13N-ammonia (there is no carrier); Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <40%).