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NCT06788535 · ClinicalTrials.gov registry record · Phase 3
Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis
A Phase 3 study of Cardiac Amyloidosis, sponsored by Sharmila Dorbala.
- Active
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT06788535: Active Phase 3 study of Cardiac Amyloidosis, sponsored by Sharmila Dorbala.
NCT06788535 is a Phase 3 study of Cardiac Amyloidosis that is active but no longer recruiting, run by Sharmila Dorbala. The registered enrollment target is 200 participants, below the 930-participant average among 8 other Cardiac Amyloidosis trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06788535, a Phase 3 study of Cardiac Amyloidosis, is active but no longer recruiting, sponsored by Sharmila Dorbala.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this Phase 3, open label, single dose imaging study is to evaluate the efficacy and safety of I-124 evuzamitide (radioactive dye) for diagnosing Cardiac Amyloidosis in participants with suspected Cardiac Amyloidosis. The imaging test that will be used in this study is a Positron Emission Tomography Computed Tomography (PET/CT) scan.
Primary Outcome
Assessment of the sensitivity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation.
Conditions Studied
Interventions
- DRUG I-124 evuzamitide
Study Locations (20)
California
- City of Hope - Duarte - Duarte
- University of California - San Francisco
Illinois
- Northwestern University - Chicago
- Cook County Health - Chicago
Missouri
- St. Lukes (CVIT) Saint Luke's Health System - Kansas City
- Washington University of St. Louis - St Louis
North Carolina
- Duke University - Durham
- Cone Health - Greensboro
Arizona
- Mayo Clinic - Scottsdale
Connecticut
- Yale Cardiovascular Medicine - New Haven
Florida
- Cleveland Clinic - Weston
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-01-14 |
| Est. Completion | 2026-02-13 |
| Phase | Phase 3 |
What the registry record for NCT06788535 still lists
NCT06788535 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 930-participant average among 8 other Cardiac Amyloidosis trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Cardiac Amyloidosis appearing as the primary indexed condition, and to 1 intervention - of which I-124 evuzamitide is the first listed.
NCT06788535 names 20 study sites across 16 states, led by California, Illinois, Missouri.
Frequently Asked Questions
What is clinical trial NCT06788535 about?
NCT06788535 is a clinical study titled "Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis". The purpose of this Phase 3, open label, single dose imaging study is to evaluate the efficacy and safety of I-124 evuzamitide (radioactive dye) for diagnosing Cardiac Amyloidosis in participants with suspected Cardiac Amyloidosis. The imaging test that will be used in this study is a Positron Emiss...
What is the current status of trial NCT06788535?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2025-01-14. Estimated completion is 2026-02-13.
What conditions does trial NCT06788535 study?
This clinical trial studies the following conditions: Cardiac Amyloidosis.
What interventions are being tested in trial NCT06788535?
The interventions under investigation include: I-124 evuzamitide (DRUG).
Who is sponsoring clinical trial NCT06788535?
This trial is sponsored by Sharmila Dorbala, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06788535 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06788535's enrollment target sits among peer trials
200 4th of 8 higher than 4 of 8 other Cardiac Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiac Amyloidosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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