PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels

ConditionsAmyloidogenic Transthyretin (ATTR) Amyloidosis Cardiac Amyloidosis

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorLorena Saelices

About this trial

The goal of this study is to learn whether PET-CT imaging using evuzamitide can help diagnose transthyretin cardiac amyloidosis (ATTR-CA) in patients whose standard nuclear imaging results are unclear but who have elevated TAD1 levels in their blood. The main question it aims to answer is:

Can evuzamitide PET-CT imaging detect signs of cardiac amyloidosis in patients with non-diagnostic nuclear scintigraphy but elevated TAD1 levels? Participants who meet eligibility criteria will receive a single PET-CT scan with evuzamitide and will be followed for approximately 28 days to monitor safety and collect additional clinical information.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed as having heart failure or TTR variant allele carriers without symptoms of heart failure.

Non-diagnostic nuclear scintigraphy for ATTR-CA (Perugini Grade 0 or 1).

Elevated levels of Transthyretin Amyloid Detector-1 (TAD1).

No evidence of monoclonal proteins by assessment of serum kappa and lambda free light chain ratio and immunofixation of serum and urine.

Disqualifiers

Primary amyloidosis (AL) or secondary amyloidosis (AA).

Ventricular assist device.

Disabling dementia or other mental or behavioral disease.

Enrollment in a clinical trial not approved for co-enrollment.

Trial population

Participants will be drawn from clinical practice registries and epidemiological ATTR-CA screening projects at UT Southwestern, Columbia University Irving Medical Center, and Boston Medical Center

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Evuzamitide
Drug
Eligible participants will receive a single intravenous injection of approximately 1 mCi (±10%) of 124I-evuzamitide (corresponding to \<1.5 mg peptide). PET-CT imaging will be performed approximately 4 ± 1 hours after administration to evaluate myocardial uptake.

Treatment groups

25 Participants

are divided into 2 treatment groups

Group A: Participants with heart failure, who have non-diagnostic nuclear scintigraphy and elevated TAD11 intervention

Group B: Asymptomatic TTR Variant Carriers with non-diagnostic scintigraphy and elevated TAD11 intervention

Trial outcomes

Primary outcomes

Number of Participants With Myocardial Uptake of Evuzamitide on PET/CT Imaging

The primary outcome of this study is the number (and percent) of subjects with myocardial uptake of evuzamitide on PET/CT imaging.

Time frame

At approximately 4 hours (±1 hour) post-injection on Day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lorena Saelices

Lead sponsor

University of Texas Southwestern Medical Center

Sponsor institution

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: