ClinicalTrials.gov record NCT06907849

124I-Evuzamitide PET/CT Imaging In Patients With Lumbar Spinal Stenosis and Carpal Tunnel Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

PET/CT Imaging Of Subjects With Lumbar Spinal Stenosis Or Carpal Tunnel Syndrome Using Amyloid-Reactive Peptide 124I-Evuzamitide

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.

Age60 years old and older

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2, single-group study uses an iodine-124–labeled peptide (124I-evuzamitide) with PET/CT to look for amyloid in the heart and elsewhere. It is intended for people with a history of lumbar spinal stenosis and/or carpal tunnel syndrome. Participants receive a single IV dose of the tracer and undergo PET/CT imaging.

What it is studying. The study is testing whether PET/CT imaging with the amyloid-binding tracer 124I-evuzamitide can identify cardiac and extracardiac amyloid in people who previously had lumbar spinal stenosis or carpal tunnel surgery and had amyloid-positive connective tissue at the time of surgery. Cardiac images will be visually classified as positive or negative for tracer uptake.

What the researchers hope to learn. To determine whether 124I-evuzamitide PET/CT can detect cardiac and extracardiac amyloid; to measure cardiac tracer uptake and compare it with heart imaging parameters (transthoracic echocardiography) and blood biomarkers (NT-proBNP and high-sensitivity troponin T); and to compare cardiac uptake with reported amyloid load in connective tissue from prior surgery.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This clinical trial will use the amyloid-binding radiotracer, 124I-evuzamitide, to potentially detect amyloid, in the heart and elsewhere, in patients who have a history of lumbar spinal stenosis and/or carpal tunnel syndrome.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: 124I-evuzamitide

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is a single center, open label, pilot study using an amyloid-reactive peptide labeled with iodine-124 (124I-evuzamitide) and PET/CT imaging to detect the presence of cardiac and extracardiac amyloid in patients who have undergone surgical intervention for lumbar spinal stenosis (LSS) or carpal tunnel syndrome (CTS) and who have amyloid-positive connective tissue [ligamentum flavum (LF) in LSS patients or tenosynovium in CTS patients] assessed at the time of the corrective surgery.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

The registry requires that you already have a Congo red–positive ligamentum flavum or tenosynovial specimen from prior laminectomy or carpal tunnel release surgery; the record does not say the study performs those surgeries or obtains those specimens. During the study you will receive a single IV injection of about 1 mCi of 124I-evuzamitide (up to 1 mg peptide) by IV push, wait about three hours, then have a PET/CT scan from shoulder to thigh and a 10-minute static PET image of the heart. The study also records cardiac imaging uptake and compares it with a transthoracic echocardiogram and blood tests (serum NT-proBNP and high-sensitivity troponin T) done at the same time; the record states the study period is up to 8 days from enrollment.

How the study is structured. Phase 2, interventional diagnostic study with a single treatment group and no masking. Participants receive one intravenous dose of 124I-evuzamitide (up to about 1 mCi and up to 1 mg peptide) and undergo PET/CT imaging approximately three hours after injection, including a whole-body scan from shoulder to thigh and a 10-minute static heart PET image. Images are read visually for tracer uptake. The primary outcome timeframe runs from enrollment to the end of study (8 days).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Lumbar Spinal Stenosis; Carpal Tunnel Syndrome (CTS); Cardiac Amyloidosis. Does it apply to my diagnosis?
The registry says participants are enrolled by invitation. Who decides who is invited, and how?
The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: May 22, 2025
Primary completion: March 2027 (estimated)
Study completion: May 2027 (estimated)
Target enrollment: 40 participants (estimated)
Last updated on registry: Jul 21, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: University of Tennessee Graduate School of Medicine
Collaborators: Attralus, Inc.

Participating sites (1)

University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37920 · United States

Terms used on this page · explanations by MedicalUpdates.ai

written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
PET/CT: A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
open label: No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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