NCT05635045CompletedPhase 2
Evuzamitide in PET/CT to Measure Potential Therapeutic Response in ATTR
A Follow-Up Study to Monitor Therapeutic Response in Transthyretin Cardiac Amyloidosis Using Amyloid Reactive Peptide 124I-evuzamitide (AT01) PET/CT
Source: ClinicalTrials.gov · Last updated 18 Jul 2025
Brief summary (registry, in English)
This was 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 had elapsed since their original 124I-evuzamitide PET scan. Ten previously scanned subjects re-consented to undergo another 124I-evuzamitide PET scan. Demographic, clinical and phenotypic data were collected to characterize potential changes since their previous scans.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 23 Nov 2022
- Start date
- 8 Jul 2022
- Primary completion date
- 7 May 2024
- Lead sponsor
- Columbia University
- Diseases
- Amyloidosis
- NCT number
- NCT05635045
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 10
- From 8 Jul 2022 to the primary completion date, 7 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Were enrolled in the initial pilot using 124I-Evuzamitide, on ATTR stabilizer and/or silencer therapy. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
- Continuous intravenous inotropic therapy.
Other illness
- Active malignancy or non-amyloid disease with expected survival of less than 1 year.
- Heart failure, in the opinion of the investigator, primarily caused by something other than amyloidosis.
- Impairment from stroke, injury or other medical disorder that precludes participation in the study.
- Disabling dementia or other mental or behavioral disease.
- Chronic kidney disease requiring hemodialysis or peritoneal dialysis.
Other
- Overall Inclusion Criteria:
- Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
- TTR genotype shown to be either Val122Ile or wild type.
- The presence of any of the following excludes eligibility for enrollment in this study:
- Primary amyloidosis (AL) or secondary amyloidosis (AA).
- Ventricular assist device.
- Enrollment in a clinical trial not approved for co-enrollment.
- Inability or unwillingness to comply with the study requirements.
- Patients taking heparin, or heparin derivatives (e.g. low molecular weight heparins) for anticoagulation.
- Other reason that would make the subject inappropriate for entry into this study.
Who the study is looking for
- Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
- Were enrolled in the initial pilot using 124I-Evuzamitide, on ATTR stabilizer and/or silencer therapy. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
- TTR genotype shown to be either Val122Ile or wild type.
Age in the registry: 50 years to 105 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.