ClinicalTrials.gov record NCT07605741
Fast Cardiac Bone SPECT-CZT in Transthyretin Cardiac Amyloidosis
Fast Cardiac Bone 360° SPECT-CZT Accurately Reproduces Planar Perugini ≥ 2 Classification With High Reproducibility in Transthyretin Cardiac Amyloidosis
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This retrospective observational study reviews imaging from people referred for suspected transthyretin cardiac amyloidosis. It compares fast full‑ring CZT-SPECT cardiac bone scans with standard planar bone scintigraphy acquired after 99mTc‑HMDP. The study will assess whether CZT-SPECT reproduces Perugini ≥2 classification and whether quantitative Standard Uptake Value (SUV) parameters are reproducible.
What it is studying. Whether rapid CZT-SPECT recordings can reproduce the diagnostic Perugini ≥2 result from standard planar bone scintigraphy, using either visual scoring on CZT-derived projections or quantitative SUV-based parameters, and how reproducible those approaches are.
What the researchers hope to learn. To assess whether fast CZT-SPECT can reproduce the Perugini ≥2 classification from standard planar imaging and to evaluate the reliability and reproducibility of SUV-based quantitative measurements for transthyretin cardiac amyloidosis.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- bone scintigraphy
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a retrospective study using images collected during routine bone scintigraphy for suspected ATTR-CA. During the referral period, patients underwent a fast cardiac CZT-SPECT (three-dimensional) acquisition attempted in addition to standard whole‑body planar bone imaging. The planar imaging was performed three or four hours after injection of 99mTc‑HMDP. The study compares Perugini scoring on conventional planar images with readings and quantitative metrics derived from the CZT‑SPECT images; the record does not describe other study procedures or additional tests.
How the study is structured. A retrospective review of imaging records. During the study period, patients referred for bone scintigraphy had a fast cardiac CZT-SPECT acquisition attempted and also underwent standard whole‑body planar imaging three or four hours after 99mTc‑HMDP injection. The study compares Perugini scores obtained from CZT-derived images and conventional planar images and evaluates reproducibility of visual and quantitative measures.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Cardiac Amyloidosis. Does it apply to my diagnosis?
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on ATTRv amyloidosis
This trial is also listed on this site under wild-type ATTR amyloidosis.
Important dates
- Study start
- May 30, 2026 (estimated)
- Primary completion
- Jun 30, 2026 (estimated)
- Study completion
- Jul 30, 2026 (estimated)
- Target enrollment
- 200 participants (estimated)
- Last updated on registry
- May 26, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Central Hospital, Nancy, France
- Principal investigator
- Pierre Yves MARIE, Prinicipal Investigator
Central Hospital, Nancy, France
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Pierre-Yves MARIE, MD,PhD 📞 0383153909 ext. +33 ✉ py.marie@chru-nancy.fr
- Véronique ROCH, MSc 📞 0383154276 ext. +33 ✉ v.roch@chru-nancy.fr
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- computed tomography
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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