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Could a common hand condition reveal hidden heart disease? new imaging trial investigates

NCT ID NCT06907849

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

What the study statuses mean

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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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study tests whether a radioactive tracer called 124I-evuzamitide can detect amyloid deposits in the heart and elsewhere in people aged 60 and older who have lumbar spinal stenosis or carpal tunnel syndrome. Participants will receive a single dose of the tracer and undergo a PET/CT scan. The goal is to see if this imaging method can identify cardiac amyloidosis, a serious condition that often goes undiagnosed, in people already known to have amyloid in tissue removed during surgery.

What this could mean

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

Active substance
a radioactive tracer called 124I-evuzamitide that binds to amyloid deposits for PET/CT imaging
What this could lead to
If successful, this imaging method could help identify hidden cardiac amyloidosis earlier in people with common conditions like carpal tunnel syndrome or spinal stenosis.
What could go wrong
This is a small, early-phase study focused on detection, not treatment. The tracer may not reliably distinguish amyloid types or predict disease progression.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

May 2027

An estimate. End dates often move.

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

60 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 be ≥ 60 years of age. * 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 Congo red positive ligamentum flavum or tenosynovial specimen analysis after laminectomy or carpal tunnel release surgery that is visually categorized as either "extensive" amyloid load or "mild/moderate" amyloid load by an experienced reviewer. * Those with mild/moderate amyloid load in the connective tissue who also have a history of at least one other orthopedic clinical manifestation, including, but not limited to, carpal tunnel syndrome, lumbar spinal stenosis, trigger finger, biceps tendon rupture, and shoulder/hip/knee arthroplasty. * Females must be non-pregnant and non-lactating. Exclusion Criteria: * Subjects on dialysis. * Subjects with a confirmed diagnosis of systemic amyloidosis, other than musculoskeletal tissue. * Inability or unwillingness to comply with the study requirements. * Subjects taking heparin, or heparin derivatives (e.g. low molecular weight heparins) for anticoagulation. * Inability to lie still for \~40 minutes on the PET/CT scanner. * History of iodine (potassium iodide) allergy. * Other reason that would make the subject inappropriate for entry into this study.

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial amyloidosis carpal tunnel syndrome lumbar spinal stenosis spinal stenosis

As listed by the trial registrant

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

Cardiac amyloidosis Carpal tunnel syndrome (CTS) Lumbar spinal stenosis

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Tennessee Graduate School of Medicine

    Knoxville, Tennessee, 37920, United States

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