Lumbar Spinal StenosisPhase 2NCT06907849
124I-Evuzamitide PET/CT Imaging In Patients With Lumbar Spinal Stenosis and Carpal Tunnel Syndrome
A Phase 2 study testing 124I-evuzamitide in people with Lumbar Spinal Stenosis and Carpal Tunnel Syndrome (CTS), run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Carpal Tunnel Syndrome (CTS), Cardiac Amyloidosis
- What is being tested?
- 124I-evuzamitide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2025to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37920
About this study
Official title: PET/CT Imaging Of Subjects With Lumbar Spinal Stenosis Or Carpal Tunnel Syndrome Using Amyloid-Reactive Peptide 124I-Evuzamitide
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.
Read the detailed description
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.
- Being tested
- 124I-evuzamitide
- Keywords
- iodine-124-evuzamitide, PET Imaging, Amyloidosis, Spinal Stenosis, Carpal Tunnel Syndrome, p5+14
- Medical subject headings
- Spinal Stenosis, Carpal Tunnel Syndrome, Amyloid Neuropathies, Familial, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
124I-evuzamitideDrug
Also called AT-01
124I-evuzamitide is an iodine-124 (124I) labeled 45 L-amino acid peptide (also known as p5+14) suitable for single dose PET/CT imaging. The peptide binds many forms of amyloid through multivalent electrostatic interactions with the amyloid fibril and with the ubiquitous amyloid-associated hypersulfated heparan sulfate proteoglycans.
| Study group | Role | What they receive |
|---|---|---|
| Biodistribution | Experimental | Participants will be administered ~1 mCi of 124I-evuzamitide (up to 1 mg of peptide) by IV push at a proposed rate of ~1 mL per 5 seconds. Three hours after injection, a PET/CT image acquisition from shoulder to thigh as well as a 10 min static PET image of the heart will be performed. Receives: Drug: 124I-evuzamitide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of cardiac amyloidosis using 124I-evuzamitide PET/CT imaging
Cardiac PET/CT images will be classified as either positive or negative for 124I-evuzamitide uptake based on visual interpretation.
Measured: From enrollment to the end of study is 8 days.
Secondary outcomes (3)
Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to biomarkers
Measure cardiac 124I-evuzamitide uptake and compare to contemporaneous transthoracic echocardiographic parameters, serum NT-proBNP, and high sensitivity troponin T levels
Measured: From enrollment to the end of study is 8 days.
Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to amyloid load in connective tissue
Measure cardiac 124I-evuzamitide uptake and compare to the reported amyloid load, based on Congo red staining, in connective tissue (obtained from LSS or CTS surgery)
Measured: From enrollment to the end of study is 8 days.
Detection of extracardiac amyloid using 124I-evuzamitide PET/CT imaging
Visual examination of extracardiac 124I-evuzamitide uptake in the PET/CT images
Measured: From enrollment to the end of study is 8 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start22 May 2025
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Attralus, Inc.
- Responsible party
- Sponsor
- Investigators
- Emily B. Martin, PhD, Principal investigator, University of Tennessee Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907849
- Sponsor's protocol ID
- UTGSM-172768-101
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wall JS, Martin EB, Lands R, Ramchandren R, Stuckey A, Heidel RE, Whittle B, Powell D, Richey T, Williams AD, Foster JS, Guthrie S, Kennel SJ. Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I) Evuzamitide (124I-p5+14): A Phase 1/2 Study. JACC Cardiovasc Imaging. 2023 Nov;16(11):1433-1448. doi: 10.1016/j.jcmg.2023.08.009.
PubMed 37940323
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/CT Imaging Of Subjects With Lumbar Spinal Stenosis Or Carpal Tunnel Syndrome Using Amyloid-Reactive Peptide 124I-Evuzamitide
- ClinicalTrials.gov ID
- NCT06907849
- Acronym / sponsor ID
- UTGSM-172768-101
- Keywords
- iodine-124-evuzamitide, PET Imaging, Amyloidosis, Spinal Stenosis, Carpal Tunnel Syndrome, p5+14
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Collaborators
- Attralus, Inc.
- Study start
- 22 May 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biodistribution | Experimental | Drug: 124I-evuzamitideParticipants will be administered ~1 mCi of 124I-evuzamitide (up to 1 mg of peptide) by IV push at a proposed rate of ~1 mL per 5 seconds. Three hours after injection, a PET/CT image acquisition from shoulder to thigh as well as a 10 min static PET image of the heart will be performed. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 124I-evuzamitideAlso: AT-01124I-evuzamitide is an iodine-124 (124I) labeled 45 L-amino acid peptide (also known as p5+14) suitable for single dose PET/CT imaging. The peptide binds many forms of amyloid through multivalent electrostatic interactions with the amyloid fibril and with the ubiquitous amyloid-associated hypersulfated heparan sulfate proteoglycans. | Drug | Biodistribution |
Primary outcome
Detection of cardiac amyloidosis using 124I-evuzamitide PET/CT imaging
Time frame: From enrollment to the end of study is 8 days.
Cardiac PET/CT images will be classified as either positive or negative for 124I-evuzamitide uptake based on visual interpretation.
3 secondary outcomes
Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to biomarkers
Time frame: From enrollment to the end of study is 8 days.
Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to amyloid load in connective tissue
Time frame: From enrollment to the end of study is 8 days.
Detection of extracardiac amyloid using 124I-evuzamitide PET/CT imaging
Time frame: From enrollment to the end of study is 8 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 37940323Wall JS, Martin EB, Lands R, Ramchandren R, Stuckey A, Heidel RE, Whittle B, Powell D, Richey T, Williams AD, Foster JS, Guthrie S, Kennel SJ. Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I) Evuzamitide (124I-p5+14): A Phase 1/2 Study. JACC Cardiovasc Imaging. 2023 Nov;16(11):1433-1448. doi: 10.1016/j.jcmg.2023.08.009.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily B. Martin, PhD principal investigator
University of Tennessee Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 124I-evuzamitide in people with Lumbar Spinal Stenosis and Carpal Tunnel Syndrome (CTS), run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of cardiac amyloidosis using 124I-evuzamitide PET/CT imaging (time frame: From enrollment to the end of study is 8 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06907849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.