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NCT04594941 · ClinicalTrials.gov registry record · Phase 2
A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes
A Phase 2 study, sponsored by GE Healthcare.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT04594941 is a Phase 2 study that has completed, run by GE Healthcare. The registered enrollment target is 38 participants.
The verdict
NCT04594941, a Phase 2 study, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
This was a Phase 2 prospective, randomized, crossover study of Flurpiridaz (18F) Injection for PET-MPI in participants referred for evaluation of known coronary artery disease (CAD) or for suspected CAD with intermediate to high pre-test probability (PTP). The objective is to assess the difference and variability between 2 sets of rest images synthesized by the same or 2 different manufacturing processes. Twenty-eight evaluable \[participants were enrolled in this study and underwent 2 Flurpiridaz (18F) Injection PET-MPI at rest. Each participant attended a Screening Visit at least 2 days and up to 14 days prior to the first Flurpiridaz (18F) Injection PET-MPI. The participants were randomized 1:1:1:1 to 4 possible sequences of receiving 2 doses of Flurpiridaz (18F) Injection: 2 groups of 7 participants received 2 Flurpiridaz (18F) Injection doses synthesized by the same manufacturing processes (either HPLC or SPE) and 2 groups of 7 subjects will receive 2 Flurpiridaz (18F) Injection doses synthesized by different manufacturing processes (1 dose by HPLC followed by 1 dose by SPE or 1 dose by SPE followed by 1 dose by HPLC). All participants were followed up by telephone for adverse events (AEs) and serious AEs (SAEs) at 24 (+8) hours following each Flurpiridaz (18F) Injection administration.
Interventions
- DRUG Flurpiridaz (18F) Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2022-01-27 |
| Est. Completion | 2022-05-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04594941
The ClinicalTrials.gov registry entry for NCT04594941 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 99 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Flurpiridaz (18F) Injection is the first listed.
NCT04594941 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04594941 about?
NCT04594941 is a clinical study titled "A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes". This was a Phase 2 prospective, randomized, crossover study of Flurpiridaz (18F) Injection for PET-MPI in participants referred for evaluation of known coronary artery disease (CAD) or for suspected CAD with intermediate to high pre-test probability (PTP). The objective is to assess the difference a...
What is the current status of trial NCT04594941?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2022-01-27. Estimated completion is 2022-05-26.
What interventions are being tested in trial NCT04594941?
The interventions under investigation include: Flurpiridaz (18F) Injection (DRUG).
Who is sponsoring clinical trial NCT04594941?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
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