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| Name | Class |
|---|---|
| Attralus, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 124I-evuzamitide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of study is 8 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of study is 8 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily B. Martin, PhD | University of Tennessee Graduate School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Graduate School of Medicine | Knoxville | Tennessee | 37920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37940323 | Background | 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. |
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| 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) |
| 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 | From enrollment to the end of study is 8 days. |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D002349 | Carpal Tunnel Syndrome |
| D028227 | Amyloid Neuropathies, Familial |
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D017772 | Amyloid Neuropathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028226 | Amyloidosis, Familial |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D057165 | Proteostasis Deficiencies |
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