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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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 411-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (51% lower). The listed sponsor is Life Molecular Imaging, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 14 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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