REMOD-TTRNCT04535349

Quantitative Analysis of Myocardial Uptake of Bone Radiopharmaceuticals in Patients With Cardiac ATTR Amyloidosis

StatusRecruiting

PhaseNot applicable

SponsorUniversity Hospital, Caen

Primary completionJun 15, 2027 (estimated)

At risk: Primary completion moved 2 years later.

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 6, 2026 Primary completion pushed from Jun 15, 2025 to Jun 15, 2027 Show 6 more changesShow less
- Eligibility criteria expanded, about 12 words
- Trial status changed: Unknown → Recruiting
- Study completion pushed from Jun 15, 2025 to Jan 15, 2028
- Registry marked status Unknown; last known: Recruiting
- Interventions: Whole-body & CZT bone tracer imaging (SPECT) (Diagnostic Test) to Whole-body & CZT bone tracer imaging (SPECT) (Diagnostic Test)
- Publications: details revised at 1 of 1 entry
Notable Jan 29, 2025 Primary and study completion dates pushed to Jun 15, 2025v4
Notable Mar 8, 2022 Primary completion date: Sep 15, 2021 to Sep 15, 2022
- Study completion date: Mar 15, 2022 to Mar 15, 2023
v3
Notable Jul 27, 2021 Trial status: Not Yet Recruiting to Recruiting
- Primary endpoints revised (3)
- Study sites: 0 to 2
- Start date changed from estimate of Sep 15, 2020 to Oct 8, 2020
v2
Aug 31, 2020 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Test-retest reproducibility

Timeframe: 10 days

Correlations between the quantitative assessment of the myocardial uptake of bone tracers and semi-quantitative approaches

Timeframe: 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

Timeframe: 6 months

Arms and interventions

No cardiac ATTR amyloidosisOther

Cardiac ATTR amyloidosis, no treatment with tafamidis plannedOther

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 plannedOther

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

Diagnostic tests: Whole-body & CZT bone tracer imaging (SPECT)

Sites

2 sites in 1 country

About this trial

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.

Trial details

Enrollment: 35 participants (estimated)
Started: Oct 8, 2020
Study completion: Jan 15, 2028 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, non-randomized, open label, diagnostic
Oversight: No data monitoring committee
Conditions: Amyloid Neuropathies, Familial, Amyloidosis Transthyretin
Collaborators: Pfizer
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
First posted: Sep 1, 2020
Registry updated: Nov 9, 2026
Last verified: Nov 2026

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