Absolute quantification of myocardial blood flow in human subjects with SYN2 dynamic PET imaging

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Synektik S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

3 Sep 2024 → ongoing

Decision date (initial)

2024-01-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Synektik S.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

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.

Secondary objectives 3

1. To identify potential sources of errors in quantitation of flow when the model is applied in patients
2. To evaluate inter- and intraobserver reproducibility of flow results of SYN2 PET MPI
3. To assess the safety of SYN2 PET MPI in patients with suspected CAD.

Conditions and MedDRA coding

Coronary Artery Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. The subject must be willing and able to provide signed and dated informed consent form prior to any study related procedures.
2. Agreement to adhere to Lifestyle Considerations (see section 6.4) throughout the study duration.
3. Male or female, over 18 years of age.
4. Patient with CAD suspicion based on symptoms and/or ECG changes as assessed by the referring physician.
5. 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.
6. The subject is able and willing to comply with all study procedures as described in the protocol.
7. Must be capable of undergoing the pharmacological (adenosine or regadenoson) stress imaging (PET-CT) protocols.
8. Willingness to abstain sexual intercourse at least 24 hours before and after the tracer administration.
9. For females of reproductive potential: use of sufficiently effective contraception during study participation (from Screening) and for 30 days after the last IMP administration.
10. 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.
11. The patient agrees to receive the maximal total radiation dose up to 10 mSv during diagnostic procedures.

Exclusion criteria 9

1. 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.
2. Patients incapable of undergoing pharmacological cardiac stress testing.
3. 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.
4. Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <40%).
5. Patients undergoing evaluation for heart transplantation or with history of heart transplantation.
6. 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.
7. Female subject has a positive (+) pregnancy test, the possibility of pregnancy cannot be ruled out prior to dosing, or the subject is breast-feeding.
8. Known allergy or hypersensitivity for SYN2 components and other acridine derivatives such as Aminacrine, Ethacridine and Euflavine.
9. Known allergy or hypersensitivity for 13N-ammonia (there is no carrier)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The agreement of flow estimates between 13N-ammonia and SYN2.

Secondary endpoints 3

1. Variability of flow estimates as compared to 13N-ammonia due to patient characteristics (sex, weight, body weight index, hematocrit) and motion and sensitivity of flow measurements to model parameters.
2. The coefficient of variation (CV)% of repeated analyses within and between two different observers in scans performed at rest and during stress are defined.
3. Adverse events and reportable serious adverse events during the resting study as defined by the NCI Common Toxicity Criteria for Adverse Events; CTCAE v.5.0.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Synektik S.A.

Sponsor organisation

Synektik S.A.

Address

Ul. Jozefa Piusa Dziekonskiego 3

City

Warsaw

Postcode

00-728

Country

Poland

Scientific contact point

Organisation

Synektik S.A.

Contact name

Przemysław Kozanecki

Public contact point

Organisation

Synektik S.A.

Contact name

Przemysław Kozanecki

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications