Evuzamitide in PET/CT to Measure Potential Therapeutic Response in ATTR

Status Recruiting

Clinical Trial Summary

This is a single center, prospective cohort study that is evaluating the ability of 124I-evuzamitide PET scanning to detect potential therapeutic changes in subjects under treatment for ATTR after one year has elapsed since their original 124I-evuzamitide PET scan. Ten previously scanned subjects will re-consent to undergo another 124I-evuzamitide PET scan. Demographic, clinical and phenotypic data will be collected to characterize potential changes since their previous scans.

Clinical Trial Description

Transthyretin cardiac amyloidosis (ATTR-CA) causes progressive heart disease that is often overlooked. It harms the heart muscle because the unstable, unfurled amyloid proteins fold up into large pieces that get caught in between layers of heart tissue, causing amyloid deposits. The earlier it is detected, the better for the patient. There is a need to improve the early diagnosis of this disease because echocardiography (sonograms of the heart) and cardiac MRI are not useful enough for this. There is an X-ray of the heart using a compound called PYP that can detect amyloid deposits earlier than ultrasound images or clinical signs, but it's not clear how early it does so. Also, it can't detect amyloid deposits outside the heart, which causes lots of pain and suffering in people with this disease. In the first phase of this study the radiation compound, evuzamitide, was shown to detect amyloidosis in the heart of selected subjects. So, the investigators want to use it to detect potential therapeutic changes in 10 subjects undergoing treatment for Transthyretin Amyloidosis: ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05635045
Study type	Interventional
Source	Columbia University
Contact	Mathew Maurer, MD
Phone	212-932-4537
Email	msm10@cumc.columbia.edu
Status	Recruiting
Phase	Phase 2
Start date	July 8, 2022
Completion date	September 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03190577` - Assessment of the Prevalence of TTR Amyloid Neuropathy in a Population of Patients With Neuropathy of Unknown Aetiology	N/A
Completed	`NCT03588468` - Expanding the Biomarkers in Familial Amyloid Neuropathy: MRI and Motor Unit Estimation by Electrophysiological Study	N/A
Completed	`NCT03591757` - Short-term Effects of TOLCAPONE on Transthyretin Stability in Subjects With Leptomeningeal TTR Amyloidosis (ATTR)	Early Phase 1
Completed	`NCT05075798` - Study of Cerebral MRI Anomalies in Mutated Transthyretin Amyloidosis Patients
Recruiting	`NCT05577819` - Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF	N/A
Terminated	`NCT04611204` - Transthyretin Cardiac Amyloidosis in Patients With Idiopathic Carpal Tunnel Syndrome Referred for Release Surgery
Completed	`NCT03352089` - Positron Emission Tomography / Magnetic Resonance Imaging in Aortic Stenosis
Recruiting	`NCT05814380` - The Regional Scintigraphic DPD Uptake in Cardiac Transthyretin Amyloidosis.
Completed	`NCT03923920` - Screening for Systemic Amyloidosis Via the Ligamentum Flavum
Completed	`NCT03886155` - Cardiac Amyloidosis Screening at Trigger Finger Release
Completed	`NCT03862807` - Patisiran in Patients With Hereditary Transthyretin-mediated Amyloidosis (hATTR Amyloidosis) Disease Progression Post-Liver Transplant	Phase 3
Completed	`NCT02792790` - Carpal Tunnel Syndrome and Amyloid Cardiomyopathy
Completed	`NCT03860935` - Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy	Phase 3
Not yet recruiting	`NCT06465810` - Non-interventional Study of Patients With Transthyretin (ATTR) Amyloidosis
Recruiting	`NCT04963985` - The Effect of Tafamidis on Transthyretin Stabilization, Safety, Tolerability and Efficacy in Transthyretin Amyloid Polyneuropathy Patients	Phase 4
Recruiting	`NCT05409833` - Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population
Completed	`NCT01171859` - Safety, Efficacy and Pharmacokinetics of Doxycycline Plus Tauroursodeoxycholic Acid in Transthyretin Amyloidosis	Phase 2
Recruiting	`NCT03237494` - TRAMmoniTTR Study Genetic Screening of an At-risk Population for hATTR and Monitoring of TTR Positive Subjects
Recruiting	`NCT04899180` - Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis	Early Phase 1
Recruiting	`NCT06345235` - New Biomarkers and Plasma Prothrombotic Potential in Cardiac Transthyretin Amyloidosis