ClinicalTrials.gov record NCT04535349
Quantitative Analysis of Myocardial Uptake of Bone Radiopharmaceuticals in Patients With Cardiac ATTR Amyloidosis
Quantitative Analysis of Myocardial Uptake of 99mTclabeled Bone Radiopharmaceuticals Using New Whole-body CZT-based SPECT-CT Cameras, at Baseline and During Medical Treatment With Tafamidis in Patients With Cardiac Transthyretin Amyloidosis
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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 study compares a new quantitative SPECT-CT method with standard semi‑quantitative reading to measure heart uptake of 99mTc bone tracers in people with suspected cardiac transthyretin (ATTR) amyloidosis. Participants have two baseline scans (test–retest). If diagnosed with cardiac ATTR, they have an echocardiogram at 3 months and both SPECT imaging and echocardiography at 6 months; some will start tafamidis as planned. The study looks at measurement repeatability, agreement with semi‑quantitative scores, and change in measurements after 6 months of tafamidis treatment.
What it is studying. The study tests whether a quantitative measure of myocardial uptake from new whole‑body CZT-based SPECT-CT scans is reproducible (test–retest), how it correlates with conventional semi‑quantitative readings, and how those measurements change six months after starting tafamidis in patients with confirmed cardiac ATTR amyloidosis.
What the researchers hope to learn. To determine the repeatability of quantitative CZT SPECT-CT measurements of myocardial 99mTc bone tracer uptake; to compare quantitative values with semi‑quantitative scores; and to assess changes in quantitative uptake after six months of tafamidis treatment.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Introduction: Transthyretin cardiac amyloidosis (ATTR) is an important cause of heart failure. Cardiac planar radionuclide imaging using 99mTc-labeled bone seeking radiopharmaceuticals is used as a noninvasive diagnostic criterion in patients without detectable monoclonal protein. The visual assessment remains the main noninvasive criterion for the diagnosis. Medical therapy using tafamidis meglumine that binds to transthyretin and prevents amyloidogenesis, recently demonstrated a reduction in all-cause mortality and cardiovascular-related hospitalizations. As a consequence, there is a need for quantitative approaches that would be useful for diagnosis and prognosis assessment but also for the evaluation of patient therapeutic response. Materials and methods: The investigators aim to include 35 patients with a suspected diagnosis of cardiac ATTR amyloidosis in whom a cardiac planar radionuclide imaging using 99mTc-labeled bone seeking radiopharmaceuticals is planned as part of routine noninvasive diagnosis work-up. Using a test-retest approach, the aim is to compare a quantitative method vs. conventional semi-quantitative approaches for the assessment of cardiac uptake of bone radiopharmaceuticals using new 3D CZT-based SPECT-CT cameras in patients with suspected cardiac ATTR amyloidosis. The investigators estimated that 20 patients will have a diagnosis of cardiac ATTR amyloidosis. In the latter patients, the aim is to evaluate the impact of 6-month therapy using tafamidis on quantitative and semi-quantitative assessment of cardiac uptake of bone radiopharmaceuticals Perspectives: This new non invasive imaging techniques for the quantitative assessment of the amyloid burden in patients with cardiac ATTR amyloidosis may help identify the responders and the patients who should benefit from dose intensification.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Diagnostic test
- Whole-body & CZT bone tracer imaging (SPECT)
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or clinical evidence of HF (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures that required/requires treatment with a diuretic for improvement, and an increase of BNP >200 pg/mL and/or NT-proBNP >500 pg/mL
- Suspected cardiac ATTR amyloidosis
- Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness > 12 mm
- Patient signed consent
- Contraception method
Exclusion criteria
- New York Heart Association (NYHA) functional class IV despite diuretic treatment
- Life expectancy <6 month due to the severity of cardiac amyloidosis and/or comorbidities
- Aortic valve surgical or percutaneous replacement within 30 days or planned within months
- Presence of primary (light chain) amyloidosis
- Contraindication to tafamidis
- Pregnancy and breast feeding ; pregnancy test in women of reproductive age irrespective of contraception method)
- Adults with protective measures
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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.
Participants will have a baseline cardiac ultrasound (echocardiography) and a whole-body CZT SPECT-CT bone tracer scan. A second SPECT-CT scan will be done 3–10 days later to test reproducibility. If imaging shows cardiac ATTR and tafamidis treatment is planned, patients will start tafamidis and return for an echocardiogram at 3 months and repeat SPECT-CT plus echocardiography at 6 months; if imaging shows no cardiac ATTR (Perugini 0), no further follow-up is planned. Women of reproductive age will have pregnancy testing as part of screening.
How the study is structured. Interventional diagnostic study with three parallel groups: no cardiac ATTR, cardiac ATTR with tafamidis planned, and cardiac ATTR without tafamidis planned. All participants receive whole-body CZT SPECT-CT imaging with a 99mTc bone tracer at baseline and a repeat scan 3–10 days later (test–retest). For those with confirmed cardiac ATTR, echocardiography is repeated at 3 months and both imaging and echocardiography are repeated at 6 months. The study is non-randomized and not masked.
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 Amyloidosis Transthyretin. Does it apply to my diagnosis?
- The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- 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
- Oct 8, 2020
- Primary completion
- Jun 15, 2025 (estimated)
- Study completion
- Jun 15, 2025 (estimated)
- Target enrollment
- 35 participants (estimated)
- Last updated on registry
- Jan 31, 2025
- 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
- University Hospital, Caen
- Collaborators
- Pfizer
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.
- Damien Legallois, MD 📞 33230165709 ✉ damien.legallois@unicaen.fr
Participating sites (2)
- CHU de CaenRecruiting
Caen, 14000 · France
- Clinique du BoisRecruiting
Lille, 59000 · France
Terms used on this page · explanations by MedicalUpdates.ai
- CT
- 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.
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- Life expectancy
- Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
- Contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- 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.
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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