Test-retest reproducibility of myocardial 99mTc-HMDP uptake quantification by SPECT-CT in suspected transthyretin cardiac amyloidosis.
Damien Legallois, Lucas Turcan, Denis Agostini...
https://pubmed.ncbi.nlm.nih.gov/40518108/Actively Recruiting
Led by University Hospital, Caen · Updated on 2025-01-31
35
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are studying transthyretin cardiac amyloidosis ATTR, a cause of heart failure, by evaluating new methods to measure the hearts uptake of bone radiopharmaceuticals. This research compares a new quantitative imaging approach using advanced 3D CZT-based SPECT-CT cameras against the standard semi-quantitative methods. The study also aims to assess how treatment with tafamidis, a medicine that binds to transthyretin and may slow disease progression, affects these imaging measurements over six months. Participants undergo cardiac echocardiography and whole-body & CZT bone tracer imaging SPECT at the start. A second imaging test is done 3 to 10 days later to confirm the diagnosis and perform test-retest comparisons. Depending on the diagnosis and treatment plan, some participants will have follow-up echocardiography and imaging at three and six months, especially those starting tafamidis therapy. The study groups include patients without cardiac ATTR amyloidosis, those with the condition but not treated with tafamidis, and those treated with tafamidis. During the study, participants will have heart scans and echocardiograms to monitor the amyloid burden in the heart. Researchers will analyze how consistent the imaging tests are over time and how treatment influences the hearts uptake of the radiopharmaceuticals. The main outcomes include test-retest reproducibility within 10 days and changes in myocardial uptake at six months after starting tafamidis. This monitoring may help identify patients who respond to treatment or need adjusted therapy. The total study duration includes initial testing and up to six months of follow-up.
CONDITIONS
Quantitative Analysis of Myocardial Uptake of Bone Radiopharmaceuticals in Patients With Cardiac ATTR Amyloidosis
D
Damien Legallois, MD
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University Hospital, Caen
Lead Sponsor
Pfizer
Collaborating Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days
Participants undergo cardiac echocardiography and whole-body & CZT bone tracer imaging (SPECT) at baseline and a second imaging within 3 to 10 days for test-retest assessment of myocardial uptake of bone radiopharmaceuticals.
2 visits (in-person)
Duration - 6 months
Participants with cardiac ATTR amyloidosis are monitored through cardiac echocardiography and whole-body & CZT bone tracer imaging (SPECT) at 3 and 6 months. Participants starting tafamidis treatment begin monitoring after treatment initiation.
2 visits (in-person) over 6 months
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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Damien Legallois, Lucas Turcan, Denis Agostini...
https://pubmed.ncbi.nlm.nih.gov/40518108/University Hospital, Caen
Lead Sponsor
Pfizer
Collaborating Sponsor