New PET tracer could spot rare heart disease without a biopsy

NCT ID NCT05184088

Completed Diagnosis Sponsor: Lantheus Germany GmbH Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This completed Phase 3 study tested whether a radioactive tracer called [18F]Florbetaben, used in PET scans, can accurately diagnose cardiac AL amyloidosis—a condition where abnormal proteins build up in the heart. 244 adults with suspected cardiac amyloidosis received a single PET scan. The goal was to see if the scan could identify the disease as reliably as a heart biopsy or other standard tests.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: [18F]Florbetaben (a radioactive tracer used in PET scans)
What this could lead to: If successful, this imaging method could provide a non-invasive way to diagnose cardiac AL amyloidosis, potentially reducing the need for heart biopsies.
What could go wrong: This is a diagnostic study, not a treatment. The imaging may not be accurate enough to replace current diagnostic methods, and results may not apply to all types of amyloidosis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

AL amyloidosis Amyloid Neuropathies, Familial amyloidosis hereditary amyloidosis Immunoglobulin Light-chain Amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AL AMYLOIDOSIS ATTR AMYLOIDOSIS CARDIAC AMYLOIDOSIS

Contacts and locations

Locations

Charite Berlin

Berlin, 13353, Germany
Clínica Universidad de Navarra

Pamplona, 31008, Spain
HOPA Hamburg

Hamburg, 22767, Germany
Hospital University Bellvitge

Barcelona, 08907, Spain
Hospital University Puerta de Hierro

Madrid, 28222, Spain
Royal Free Hospital

London, NW3 2PF, United Kingdom
St Luke's Hospital

Kansas City, Kansas, 64111, United States
University of Augsburg

Augsburg, 86156, Germany
University of Essen

Essen, 45147, Germany
University of Heidelberg

Heidelberg, 69120, Germany
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States
University of Salamanca

Salamanca, 37007, Spain
University of Würzburg

Würzburg, 97080, Germany

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