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Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
NCT05184088 · View on ClinicalTrials.gov ↗
Study Summary
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq \[18F\]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.
Conditions Studied
Interventions
- DRUG [18F]florbetaben
Study Locations (14)
Other
- University of Augsburg — Augsburg
- Charite Berlin — Berlin
- University of Essen — Essen
- HOPA Hamburg — Hamburg
- University of Heidelberg — Heidelberg
- University of Würzburg — Würzburg
- Hospital University Bellvitge — Barcelona
- Hospital University Puerta de Hierro — Madrid
- Clínica Universidad de Navarra — Pamplona
- University of Salamanca — Salamanca
- Royal Free Hospital — London
Pennsylvania
- University of Pennsylvania — Philadelphia
- University of Pittsburgh — Pittsburgh
Kansas
- St Luke's Hospital — Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-01-13 |
| Est. Completion | 2026-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05184088
The ClinicalTrials.gov registry entry for NCT05184088 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Life Molecular Imaging, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with AL Amyloidosis appearing as the primary indexed condition, and to 1 intervention — of which [18F]florbetaben is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05184088 reports 14 study locations spanning 3 distinct geographic areas — top geographies include Other, Pennsylvania, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05184088 about?
NCT05184088 is a clinical study titled "Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis". This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq \[18F\]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.
What is the current status of trial NCT05184088?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2023-01-13. Estimated completion is 2026-03.
What conditions does trial NCT05184088 study?
This clinical trial studies the following conditions: AL Amyloidosis, Cardiac Amyloidosis, ATTR Amyloidosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05184088?
The interventions under investigation include: [18F]florbetaben (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05184088?
This trial is sponsored by Life Molecular Imaging, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05184088 being conducted?
This trial has 14 study locations across Kansas, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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