Clinical Trial: Evuzamitide in PET/CT to Measure Potential Therapeutic Response in ATTR
Study Status: COMPLETED
Recruit Status: COMPLETED
Study Type: INTERVENTIONAL
Official Title: A Follow-Up Study to Monitor Therapeutic Response in Transthyretin Cardiac Amyloidosis Using Amyloid Reactive Peptide 124I-evuzamitide (AT01) PET/CT
Brief 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.
Detailed Summary:
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:
Sponsor: Columbia University
Current Primary Outcome:
Detection of TTR cardiac infiltration.
To determine if 124I-evuzamitide PET scanning can detect cardiac TTR amyloidosis in subjects with heart failure, increased wall thickness but only grade 1 Tc99-PYP scans who are either not currently diagnosed with ATTR-CM or have endomyocardial biopsy evidence of ATTR-CM.
The organ-specific radioactivity data will be expressed as the mean and standard deviation (SD) of three independent ROIs, unless otherwise noted.
The coefficient of variation (COV) will be expressed as (SD/mean)*100.
Original Primary Outcome:
Detection of TTR cardiac infiltration.
To determine if 124I-evuzamitide PET scanning can detect cardiac TTR amyloidosis in subjects with heart failure, increased wall thickness but only grade 1 Tc99-PYP scans who are either not currently diagnosed with ATTR-CM or have endomyocardial biopsy evidence of ATTR-CM.
The organ-specific radioactivity data will be expressed as the mean and standard deviation (SD) of three independent ROIs, unless otherwise noted.
The coefficient of variation (COV) will be expressed as (SD/mean)*100.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Columbia University
Dates:
Date Received: November 23, 2022
Date Started: July 08, 2022
Date Completion: June 12, 2024
Last Updated: July 10, 2024
Last Verified: July 01, 2024
