MedTrace Logo

Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis

NCT05184088 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-11-25

No results posted yet for this 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

  • Cardiac Amyloidosis
  • AL Amyloidosis
  • ATTR Amyloidosis

Interventions

DRUG

[18F]florbetaben

All enrolled patients will undergo \[18F\]florbetaben PET imaging.

Sponsors & Collaborators

  • pharmtrace klinische Entwicklung GmbH

    collaborator UNKNOWN

  • Life Molecular Imaging GmbH

    lead INDUSTRY

Principal Investigators

  • Andrew Stephens, MD, PhD · Life Molecular Imaging

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-13
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05184088 on ClinicalTrials.gov