Cure My Disease

Don't miss your cure!

 Log in / Sign up

A new scan aims to watch amyloid deposits in the body over time

NCT ID NCT05968846

Diagnosis Sponsor: University of Tennessee Graduate School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This study tests whether a special PET/CT scan can measure changes in amyloid deposits in organs of people with systemic amyloidosis. Participants receive an injection of a radiolabeled peptide that binds to amyloid, then undergo imaging at different times. Researchers compare the scan results with each person's disease status to see if the imaging can track organ-specific amyloid load. The goal is to develop a noninvasive way to monitor disease progression and response to treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
An injectable peptide (124I-AT-01, also called evuzamitide) that binds to amyloid deposits and is visible on PET/CT scans.
What this could lead to
If it works, this imaging method could let doctors monitor amyloid buildup in organs over time, helping guide treatment decisions without repeated biopsies.
What could go wrong
This is a small Phase 2 study, so the imaging changes may not reliably match disease status. The peptide involves radiation exposure from the iodine-124 label, and results may not apply to all amyloidosis types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

19 people

The number who actually took part.

Started

Dec 2022

Finished

Sep 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * Must have a diagnosis of systemic amyloidosis based on the patient's medical record. * Must have undergone PET/CT imaging with 124I-AT-01 as part of the AMY1001 study (IND #132282) with visually positive uptake of radiotracer in at least one abdominothoracic organ. * Must have been imaged with 124I-AT-01 as part of the AMY1001 study (IND #132282) more than 12 months prior to repeat imaging. * Females: must be non-pregnant and non-lactating and either: surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy); post-menopausal (defined as 12 months of spontaneous amenorrhea in females \> 55 years of age or, in females ≤ 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the laboratory involved). Exclusion Criteria: * Disabling dementia or other mental or behavioral disease. * Patients on dialysis. * 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. * Inability to lie still for 60 minutes on the PET/CT scanner. * History of iodine (potassium iodide) allergy. * Positive ADA finding defined as significantly higher than normal human serum mean values AND with a mean value at least five times greater than the mean value of the normal human serum control.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Systemic amyloidosis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Immunoglobulin Light-chain Amyloidosis primary systemic amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic amyloidosis

Contacts and locations

Locations

  • University of Tennessee Graduate School of Medicine

    Knoxville, Tennessee, 37920, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.