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Not yet recruiting NCT07605741

Fast Cardiac Bone SPECT-CZT in Transthyretin Cardiac Amyloidosis

Observational Cardiac Amyloidosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bone scintigraphy.
Who it may be relevant to
Registry conditions: Cardiac Amyloidosis. Basic parameters: 18 years — 95 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Fast Cardiac Bone 360° SPECT-CZT Accurately Reproduces Planar Perugini ≥ 2 Classification With High Reproducibility in Transthyretin Cardiac Amyloidosis

Overview

Transthyretin cardiac amyloidosis (ATTR-CA) is traditionally diagnosed using planar bone scintigraphy with a Perugini visual score ≥ 2. Fast cardiac CZT-SPECT will be evaluated for its ability to reproduce this classification and provide reproducible quantitative myocardial uptake metrics.

Detailed description

Transthyretin cardiac amyloidosis (ATTR-CA) has emerged as a major cause of infiltrative cardiomyopathy, and early diagnosis is associated with improved prognosis. ATTR is now recognized far more frequently than in the past, owing to increased clinical awareness and advances in non-invasive imaging strategies, including planar bone scintigraphy.

In the absence of monoclonal gammopathy, a Perugini grade ≥ 2 on planar bone scintigraphy constitutes a highly specific diagnostic criterion for ATTR-CA, obviating in most cases the need for endomyocardial biopsy. Consequently, planar bone scintigraphy acquired with conventional Anger cameras has become the reference method in this setting.

In recent years, full-ring cadmium-zinc-telluride (CZT) single-photon emission computed tomography (SPECT) whole-body cameras have rapidly emerged. These systems offer enhanced image quality and count sensitivity, mainly due to the high intrinsic detection efficiency of CZT detectors and a dedicated full-ring geometry that optimizes photon collection over the patient's body or specific organs of interest. They have enabled the development of ultrafast three-dimensional acquisitions combined with SUV-based image scaling, thereby improving patient comfort and throughput, while also allowing lesion quantification.

However, the ability of rapid CZT-SPECT/CT acquisitions to accurately replicate the ATTR-CA diagnostic information obtained from standard planar imaging remains insufficiently documented. Furthermore, although CZT-SPECT/CT technology allows for precise quantification, it has not yet been established whether Standard Uptake Value (SUV) based parameters can serve as reliable and reproducible imaging biomarkers for ATTR-CA Therefore, the aim of this retrospective study will be to (i) evaluate whether fast CZT-SPECT recordings can reproduce the diagnosis of ATTR-CA obtained using Perugini scoring on standard planar images, either by applying Perugini scoring to planar projections or by using quantitative parameters, and (ii) compare the reproducibility of these approaches.

Interventions

  • Other bone scintigraphy
    Fast CZT camera bone scintigraphy and bone scintigraphy with conventional camera (standard care)

Primary outcome measures

  • to evaluate whether fast CZT-SPECT recordings can reproduce the diagnosis of ATTR-CA obtained using Perugini scoring on standard planar images, either by applying Perugini scoring to planar projections or by using quantitative parameters [Time frame: one day]

Eligibility criteria

Inclusion criteria

  • Patients who were routinely referred for bone scintigraphy for suspected transthyretin cardiac amyloidosis (ATTR-CA) between April 2024 and April 2025.

Exclusion criteria

  • Patients who object to the use of their data

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07605741 · 2025PI149

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗