Fast Cardiac Bone SPECT-CZT in Transthyretin Cardiac Amyloidosis (PeakAmyL)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Amyloidosis
• Intervention / Treatment: Other: bone scintigraphy

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Véronique ROCH, MSc; Phone Number: +33 0383154276; Email: v.roch@chru-nancy.fr
• Study Contact Backup: Name: Pierre-Yves MARIE, MD,PhD; Phone Number: +33 0383153909; Email: py.marie@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Retrospectively enrolled patients routinely referred for bone scintigraphy for suspected transthyretin cardiac amyloidosis (ATTR-CA) . During this period, a rapid three-dimensional CZT-SPECT cardiac acquisition was systematically attempted in addition to conventional planar imaging, depending on camera availability, for diagnostic purposes, particularly for identifying blood-pool activity and other extracardiac confounding uptake areas

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients referred for bone scintigraphy for suspected ATTR-CA; Patients referred for bone scintigraphy for suspected ATTR-CA underwent a fast cardiac CZT-SPECT acquisition followed by standard whole-body planar imaging three or four hours after 99mTc-HMDP injection	Other: bone scintigraphy; Fast CZT camera bone scintigraphy and bone scintigraphy with conventional camera (standard care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Comparison between Perugini score obtained on the bone scan scintigraphy performed with CZT SPECT and performed with conventional camera	one day

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac amyloidosis, Bone scans, CZT, SPECT-CT, Perugini
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Peripheral Nervous System Diseases; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Proteostasis Deficiencies; Amyloid Neuropathies; Amyloidosis, Familial; Amyloidosis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Amyloid Neuropathies, Familial
• Other Study ID Numbers: 2025PI149

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No