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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507520-23-00
Acronym
SAFER2a
Enrollment
30
Registered
2024-01-22
Start date
2024-09-03
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief summary

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

Detailed description

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., The coefficient of variation (CV)% of repeated analyses within and between two different observers in scans performed at rest and during stress are defined., 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.

Interventions

Sponsors

Synektik S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
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., The coefficient of variation (CV)% of repeated analyses within and between two different observers in scans performed at rest and during stress are defined., 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.

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026