Amyloidosis TransthyretinREMOD-TTRNCT04535349
Quantitative Analysis of Myocardial Uptake of Bone Radiopharmaceuticals in Patients With Cardiac ATTR Amyloidosis
A study testing Whole-body & CZT bone tracer imaging (SPECT) in people with Amyloidosis Transthyretin, run by University Hospital, Caen at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Amyloidosis Transthyretin
- What is being tested?
- Whole-body & CZT bone tracer imaging (SPECT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Oct 2020to 15 Jun 2025
- Phase
- Interventional
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU de Caen
Caen, 14000
- Recruiting
Clinique du Bois
Lille, 59000
About this study
Official title: 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
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.
- Conditions
- Amyloidosis Transthyretin
- Being tested
- Whole-body & CZT bone tracer imaging (SPECT)
- 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.
Whole-body & CZT bone tracer imaging (SPECT)Diagnostic test
Quantitative analysis of myocardial uptake of 99mTc-labeled bone radiopharmaceuticals using new whole-body CZT-based SPECT-CT cameras
| Study group | Role | What they receive |
|---|---|---|
| No cardiac ATTR amyloidosis | Other | Cardiac echocardiography at baseline and whole-body \& CZT bone tracer imaging (SPECT).
day 3 - day 10 : second whole-body \& CZT bone tracer imaging (SPECT), test-retest Bone tracer imaging Perugini 0 : no cardiac TTR amyloidosis No further follow-up. Receives: Diagnostic Test: Whole-body & CZT bone tracer imaging (SPECT) |
| Cardiac ATTR amyloidosis, no treatment with tafamidis planned | Other | Cardiac echocardiography at baseline and whole-body \& CZT bone tracer imaging (SPECT).
day 3 - day 10 : second whole-body \& CZT bone tracer imaging (SPECT), test-retest Bone tracer imaging demonstrating cardiac ATTR amyloidosis but no treament with tafamidis planned.
Cardiac echocardiography at 3 months and whole-body \& CZT bone tracer SPECT and cardiac echocardiography at 6 months Receives: Diagnostic Test: Whole-body & CZT bone tracer imaging (SPECT) |
| Cardiac ATTR amyloidosis, treatment with tafamidis planned | Other | Cardiac echocardiography at baseline and whole-body \& CZT bone tracer imaging (SPECT).
day 3 - day 10 : second whole-body \& CZT bone tracer imaging (SPECT), test-retest Bone tracer imaging demonstrating cardiac ATTR amyloidosis. Start of the treament with tafamidis.
Cardiac echocardiography at 3 months and whole-body \& CZT bone tracer SPECT and cardiac echocardiography at 6 months Receives: Diagnostic Test: Whole-body & CZT bone tracer imaging (SPECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest reproducibility
Test-retest repeatability will be assessed by comparing the results from two successive 3D CZT imaging examinations performed in two distinct baseline imaging sessions. Repeatability will be evaluated by the mean absolute difference and the coefficient of variation (COV) (mean relative difference) between the results of the assessment of the 3D-myocardial uptake of bone tracers in the two examinations. A measurement will be considered reproducible when COV will be below 20%. Furthermore, the repeatability will also be assessed using the interclass correlation coefficient (ICC) and its 95% confidence interval (95%CI) under an ANOVA random effect model, and Bland Altman plots.
Measured: 10 days
Correlations between the quantitative assessment of the myocardial uptake of bone tracers and semi-quantitative approaches
Correlations between the quantitative assessment of the myocardial uptake (COV) of bone tracers and semi-quantitative approaches will be performed by using linear regression analysis performed by the least squares method and Pearson's correlation coefficient r and Bland Altman plots.
Measured: 10 days
Comparison between the quantitative assessment of the myocardial uptake of bone tracers (COV) between baseline and follow-up imaging of each patient, 6 months after the beginning of the treatment by tafamidis
The investigators will compare baseline and follow-up imaging of each patient, 6 months after the beginning of the treatment by tafamidis using paired comparison for quantitative data and concordance tests (Kappa test) for semi-quantitative data.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start8 Oct 2020
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyloidosis TransthyretinStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535349
- Sponsor's protocol ID
- 19-226
- Acronym
- REMOD-TTR
- Status last verified
- Oct 2024
- First submitted
- 17 Jul 2020
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Legallois D, Turcan L, Agostini D, Manrique A. Test-retest reproducibility of myocardial 99mTc-HMDP uptake quantification by SPECT-CT in suspected transthyretin cardiac amyloidosis. J Nucl Cardiol. 2025 Sep;51:102273. doi: 10.1016/j.nuclcard.2025.102273. Epub 2025 Jun 13.
PubMed 40518108
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04535349
- Acronym / sponsor ID
- REMOD-TTR / 19-226
- Conditions
- Amyloidosis Transthyretin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 1 Sep 2020 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No cardiac ATTR amyloidosis | Other | Diagnostic Test: Whole-body & CZT bone tracer imaging (SPECT)Cardiac echocardiography at baseline and whole-body \& CZT bone tracer imaging (SPECT). day 3 - day 10 : second whole-body \& CZT bone tracer imaging (SPECT), test-retest Bone tracer imaging Perugini 0 : no cardiac TTR amyloidosis No further follow-up. |
| Cardiac ATTR amyloidosis, no treatment with tafamidis planned | Other | Diagnostic Test: Whole-body & CZT bone tracer imaging (SPECT)Cardiac echocardiography at baseline and whole-body \& CZT bone tracer imaging (SPECT). day 3 - day 10 : second whole-body \& CZT bone tracer imaging (SPECT), test-retest Bone tracer imaging demonstrating cardiac ATTR amyloidosis but no treament with tafamidis planned. Cardiac echocardiography at 3 months and whole-body \& CZT bone tracer SPECT and cardiac echocardiography at 6 months |
| Cardiac ATTR amyloidosis, treatment with tafamidis planned | Other | Diagnostic Test: Whole-body & CZT bone tracer imaging (SPECT)Cardiac echocardiography at baseline and whole-body \& CZT bone tracer imaging (SPECT). day 3 - day 10 : second whole-body \& CZT bone tracer imaging (SPECT), test-retest Bone tracer imaging demonstrating cardiac ATTR amyloidosis. Start of the treament with tafamidis. Cardiac echocardiography at 3 months and whole-body \& CZT bone tracer SPECT and cardiac echocardiography at 6 months |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Whole-body & CZT bone tracer imaging (SPECT)Quantitative analysis of myocardial uptake of 99mTc-labeled bone radiopharmaceuticals using new whole-body CZT-based SPECT-CT cameras | Diagnostic test | Cardiac ATTR amyloidosis, no treatment with tafamidis planned, Cardiac ATTR amyloidosis, treatment with tafamidis planned, No cardiac ATTR amyloidosis |
Primary outcome
Test-retest reproducibility
Time frame: 10 days
Test-retest repeatability will be assessed by comparing the results from two successive 3D CZT imaging examinations performed in two distinct baseline imaging sessions. Repeatability will be evaluated by the mean absolute difference and the coefficient of variation (COV) (mean relative difference) between the results of the assessment of the 3D-myocardial uptake of bone tracers in the two examinations. A measurement will be considered reproducible when COV will be below 20%. Furthermore, the repeatability will also be assessed using the interclass correlation coefficient (ICC) and its 95% confidence interval (95%CI) under an ANOVA random effect model, and Bland Altman plots.
Correlations between the quantitative assessment of the myocardial uptake of bone tracers and semi-quantitative approaches
Time frame: 10 days
Correlations between the quantitative assessment of the myocardial uptake (COV) of bone tracers and semi-quantitative approaches will be performed by using linear regression analysis performed by the least squares method and Pearson's correlation coefficient r and Bland Altman plots.
Comparison between the quantitative assessment of the myocardial uptake of bone tracers (COV) between baseline and follow-up imaging of each patient, 6 months after the beginning of the treatment by tafamidis
Time frame: 6 months
The investigators will compare baseline and follow-up imaging of each patient, 6 months after the beginning of the treatment by tafamidis using paired comparison for quantitative data and concordance tests (Kappa test) for semi-quantitative data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 40518108Legallois D, Turcan L, Agostini D, Manrique A. Test-retest reproducibility of myocardial 99mTc-HMDP uptake quantification by SPECT-CT in suspected transthyretin cardiac amyloidosis. J Nucl Cardiol. 2025 Sep;51:102273. doi: 10.1016/j.nuclcard.2025.102273. Epub 2025 Jun 13.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body & CZT bone tracer imaging (SPECT) in people with Amyloidosis Transthyretin, run by University Hospital, Caen at 2 sites 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damien Legallois, MD (33230165709, damien.legallois@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-retest reproducibility (time frame: 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04535349, which also lists 1 linked publication.
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 31 Jan 2025.