PET/CT Imaging in Carriers of TTR Mutations
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-80
SponsorUniversity of Texas Southwestern Medical Center
About this trial
The purpose of this study is to determine if TTR gene carriers have early signs of a type of heart disease called amyloidosis using a new radiotracer dye (iodine-124 evuzamitide, I-124E).
Participants will undergo a screening that includes a medical history review and completion of quality-of-life surveys. Once screening is complete, participants will undergo an imaging test called a positron emission tomography (PET) scan combined with computed tomography (PET/CT) to make images of the body. The new radiotracer dye (I-124E, a radioactive contrast) will be used during the PET/CT to make amyloidosis visible in the heart and body.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
men and women ages 30-80 who are pathogenic allele TTR carriers without history of HF (this will be assessed by study personnel and defined as : 1) No history of hospitalization within the previous 12 months for management of HF; 2) Without an elevated B-type natriuretic peptide level ≥100 pg/mL or NT-proBNP ≥360 pg/mL within the previous 12 months; or 3) a clinical diagnosis of HF from a treating clinician)
have already completed the protocol for NCT05489549 at UT Southwestern only
a self-reported history or clinical history of HF
other known causes of cardiomyopathy
Disqualifiers
None
Trial population
We will enroll 50 carriers of pathogenic TTR alleles without HF, 20 patients with ATTR-CA, and 10-race matched non-carrier controls to have PET/CT I-124E imaging.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Iodine-124 Evuzamitide (I-124E)
Diagnostic testI-124E is a novel amyloidophilic peptide radiotracer that binds via electrostatic interactions to electronegative glycosaminoglycans and amyloid protein fibrils - both are ubiquitous among amyloid deposits. PET/CT I-124E has acceptable dosimetry estimates and is acceptable for whole-body PET/CT imaging. Data from patients with amyloidosis has established that tracer uptake is present in locations of clinically anticipated amyloid deposits and in locations not clinically appreciated, but also consistent with the distribution of amyloid in the human body (e.g. heart, kidney, spleen).
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: Pathogenic TTR Allele Carriers without Heart Failure1 intervention
Group B: Subjects with Symptomatic ATTR-CA1 intervention
Group C: Non-carrier race-matched controls1 intervention
Trial outcomes
Primary outcomes
1
LV % Injected dose
Evidence of subclinical cardiac amyloid infiltration as measured by PET/CT quantification imaging with I-124E. This will be defined as LV % injected dose (LV%ID = volume of interest \[VOI\] mean activity concentration in the LV X VOI volume / injected activity). LV%ID is an ideal metric to assess cardiac amyloid burden because it is: 1) correlated with validated metrics assessing cardiac amyloid burden; 2) sensitive for detection of early disease (patchy vs. diffuse uptake); and 3) highly repeatable and standardizable to other metrics of radiotracer uptake. LV%ID is adjusted for injected activity, but not for body weight, because the latter is unnecessary for a radiotracer accumulating in the heart and specific organs, not in the whole body.
Time frame
PET/CT Scan VisitSecondary outcomes
1
LVFW SUVR, mean
Time frame
PET/CT Scan Visit2
LVFW wall SUVR, max
Time frame
PET/CT Scan Visit3
IVS SUVR, mean
Time frame
PET/CT Scan Visit4
IVS SUVR, max
Time frame
PET/CT Scan VisitSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Bayer
Collaborator
Source ClinicalTrials.gov
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