Cardiac AmyloidosisPeakAmyLNCT07605741
Fast Cardiac Bone SPECT-CZT in Transthyretin Cardiac Amyloidosis
An observational study of Cardiac Amyloidosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- bone scintigraphy
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- Patients who were routinely referred for bone scintigraphy for suspected transthyretin cardiac amyloidosis (ATTR-CA) between April 2024 and April 2025.
Who cannot join
- Patients who object to the use of their data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Amyloidosis
- Being tested
- bone scintigraphy
- Keywords
- Cardiac amyloidosis, Bone scans, CZT, SPECT-CT, Perugini
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone scintigraphyOther
Fast CZT camera bone scintigraphy and bone scintigraphy with conventional camera (standard care)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: bone scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start30 Jun 2026
- Primary completion30 Jul 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Yves MARIE, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605741
- Sponsor's protocol ID
- 2025PI149
- Acronym
- PeakAmyL
- Status last verified
- Oct 2026
- First submitted
- 6 May 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Cardiac Bone 360° SPECT-CZT Accurately Reproduces Planar Perugini ≥ 2 Classification With High Reproducibility in Transthyretin Cardiac Amyloidosis
- ClinicalTrials.gov ID
- NCT07605741
- Acronym / sponsor ID
- PeakAmyL / 2025PI149
- Conditions
- Cardiac Amyloidosis
- Keywords
- Cardiac amyloidosis, Bone scans, CZT, SPECT-CT, Perugini
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred for bone scintigraphy for suspected ATTR-CA | – | Other: bone scintigraphyPatients 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 |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients who were routinely referred for bone scintigraphy for suspected transthyretin cardiac amyloidosis (ATTR-CA) between April 2024 and April 2025.
Key exclusion criteria (1 listed)
- Patients who object to the use of their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone scintigraphyFast CZT camera bone scintigraphy and bone scintigraphy with conventional camera (standard care) | Other | Patients referred for bone scintigraphy for suspected ATTR-CA |
Primary outcome
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
Comparison between Perugini score obtained on the bone scan scintigraphy performed with CZT SPECT and performed with conventional camera
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Amyloidosis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.