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NCT05184088 · ClinicalTrials.gov registry record · Phase 3
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
A Phase 3 study of AL Amyloidosis and Cardiac Amyloidosis, sponsored by Life Molecular Imaging.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 14
- Study locations
NCT05184088: Recruiting Phase 3 study of AL Amyloidosis and Cardiac Amyloidosis, sponsored by Life Molecular Imaging.
NCT05184088 is a Phase 3 study of AL Amyloidosis and Cardiac Amyloidosis that is actively recruiting participants, run by Life Molecular Imaging. The registered enrollment target is 200 participants, below the 411-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (51% lower). The trial reports 14 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05184088, a Phase 3 study of AL Amyloidosis and Cardiac Amyloidosis, is actively recruiting participants, sponsored by Life Molecular Imaging.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 14
- Study locations
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.
Primary Outcome
The results from the visual assessment of \[18F\]florbetaben PET images are compared to the clinical diagnosis established through histological verification of the presence or absence of AL amyloidosis with cardiac involvement determined either through endomyocardial biopsy or through extracardiac biopsy in conjunction with typical CMR or echocardiography imaging features as the standard of truth.
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 |
What NCT05184088 shows while recruiting
NCT05184088 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 411-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (51% lower).
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.
NCT05184088 lists 14 locations in 3 states (Other, Pennsylvania, Kansas).
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.
What interventions are being tested in trial NCT05184088?
The interventions under investigation include: [18F]florbetaben (DRUG).
Who is sponsoring clinical trial NCT05184088?
This trial is sponsored by Life Molecular Imaging, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for AL Amyloidosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05184088's enrollment target sits among peer trials
200 4th of 15 higher than 12 of 15 other AL Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other AL Amyloidosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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