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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Lorena Saelices
Study ID
NCT07538518
Status
Not Yet Recruiting

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Conditions

  • Amyloidogenic Transthyretin (ATTR) Amyloidosis
  • Cardiac Amyloidosis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Mar 15, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
25 participants (estimated)

Arms

  • Arm: Participants with heart failure, who have non-diagnostic nuclear scintigraphy and elevated TAD1
    This cohort includes subjects with heart failure who have non-diagnostic nuclear scintigraphy (Perugini Grade 0 or 1) and elevated TAD1 levels.
  • Arm: Asymptomatic TTR Variant Carriers with non-diagnostic scintigraphy and elevated TAD1
    This cohort includes non-symptomatic carriers of transthyretin (TTR) variants who have non-diagnostic nuclear scintigraphy (Perugini Grade 0 or 1) and elevated TAD1 levels.

Primary Outcome Measure

Number of Participants With Myocardial Uptake of Evuzamitide on PET/CT Imaging [ Time Frame: At approximately 4 hours (±1 hour) post-injection on Day 1 ]

Central Contacts

  • Lorena Saelices Gomez, Ph.D.
    323-847-9327
    [email protected]
  • Shumaila Afrin, Ph.D.
    214-677-5721

Locations (3)

FacilityCityStateZIPSite coordinators
One Boston Medical Center PlaceBostonMassachusetts02118
Frederick Ruberg, M.D
[email protected]
617-638-8733
Denise Fine
[email protected]
Frederick Ruberg, M.D. (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Mathew Maurer, M.D
[email protected]
212-932-4537
Stephen Helmke
Mathew Maurer, M.D. (PRINCIPAL_INVESTIGATOR)
Bill and Rita Clements Advanced Medical Imaging CenterDallasTexas75235-8823
Lorena Saelices
[email protected]
2146488846

Find similar trials in Boston, MA

By research site
One Boston Medical Center Place· Boston, MAColumbia University Irving Medical Center· New York, NYBill and Rita Clements Advanced Medical Imaging Center· Dallas, TX

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