[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512389":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Tennessee Graduate School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Estimation of dosimetry for 99mTc-p5+14 and Biodistribution Of 99mtc-p5+14 In Healthy Subjects","EXPERIMENTAL","For dosimetry, healthy subjects (n=3) and patients with a confirmed diagnosis of AL (n=1) or ATTR amyloidosis (n=1) will be administered a single IV dose of up to 1 mg of 99mTc-p5+14 (\\~20 mCi) by slow push (\\~1 mL\u002F5 sec.). Subjects will then undergo serial planar scintigraphic imaging at \\~30 minutes, \\~1 hour, \\~2 hours, \\~4 hours, \\~6 hours, and \\~24 hours post-injection. At the 4-hour time point, the subject will also undergo a single SPECT\u002FCT scan to provide additional data for estimating dosimetry. Before injection of the radiotracer and at each imaging session, \\~2 -3 mL of blood will be acquired to determine the whole blood radioactivity. An echo examination will also be performed.\n\nFor physiological biodistribution, healthy volunteers (n=5) will undergo an echo examination, thereafter, they will be administered a single IV dose of 99mTc-p5+14 (20 mCi) and will undergo a planar image acquisition followed by SPECT\u002FCT imaging at \\~1 hour and \\~3 hours post-injection.",[13],"Drug: 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m.",{"label":15,"type":10,"description":16,"interventionNames":17},"Biodistribution in patients with systemic AL or ATTR amlyoidosis","On Day 1, patients with a confirmed diagnosis of systemic AL or ATTR (with or without a positive PyP scan) will be administered a single IV dose of up to 1 mg of 99mTc-p5+14 (\\~20 mCi) by slow push (\\~1 mL\u002F5 sec.). At \\~1 hour and \\~3 hours post-injection, patients will undergo whole body planar imaging followed by abdominothoracic SPECT\u002FCT imaging. Vital signs (blood pressure, respiration rate, temperature, and pulse) will be acquired before injection of the 99mTc-p5+14, and at \\~3 hours post injection. ECG measurements will be made within 1 hour prior to, and within 15 minutes after, injection.\n\nOn Day 3, patient will undergo a trans thoracic echo examination. On Day 4, patients will undergo Technescan™ 99mTc-PYP (20 mCi) planar and SPECT\u002FCT imaging at \\~1 hour and \\~3 hours post-injection. Vital signs (blood pressure, respiration rate, temperature, and pulse) will be acquired before injection of the 99mTc-PYP, and at \\~3 hours post injection. ECG measurements will be made as on Day 1.",[13,18],"Drug: 99mTc-Pyrophosphate",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m.","Peptide p5+14 is a pan-amyloid reactive, synthetic 45 L-amino acid polypeptide with a net +12 positive charge that can bind two major components of all extracellular amyloid deposits: (i) hypersulfated heparan sulfate glycosaminoglycans (proteoglycans) and (ii) amyloid fibrils. The polypeptide, labeled with iodine-124, has been shown (study AMY1001) to bind amyloid in all organs including the heart. This study will evaluate a Tc-99m-labeled version of the peptide for gamma imaging.",[15,9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"99mTc-Pyrophosphate","99mTc-PYP is an FDA-approved, commercially available bone-seeking radiotracer used routinely in nuclear medicine. 99mTC-PYP imaging is used clinically for the diagnosis of cardiac ATTR amyloidosis.",[15],[31],"99mTc-PYP",[33],{"name":34,"affiliation":5,"role":35},"Jonathan S Wall, PhD","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Emily B Martin, PhD","CONTACT","865-305-9533","emartin@utmck.edu",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Knoxville","Tennessee","37920","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-83.92074,35.96064,{"lat":54,"lon":53},[57,58],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},{"name":34,"role":35,"phone":25,"phoneExt":25,"email":25},{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[62],{"name":63,"class":64},"Bayer","INDUSTRY","100512389","phase-1-a-phase-1-study-of-99mtc-p514-in-healthy-volunteers-and-patients-with-al-or-attr-systemic-amyloidosis-100512389",false,"NCT05951816","A Phase 1 Study of 99mTc-p5+14 in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis","Phase 1 Study to Investigate the Dosimetry and Biodistribution of a Single Intravenous Administration of 99mTc-p5+14 Using SPECT\u002FCT Imaging and Planar Gamma Scintigraphy in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis","Inclusion Criteria:\n\nPART 1\n\n1\\) Understand the study procedures and agree to participate in the study by giving written informed consent..\n\n2\\) Be male or female \\>18 years of age. 3) Women of child-bearing potential (WOCBP) (those who have not been surgically sterilized, are not postmenopausal \\[i.e., last menstrual period \\>2 years ago without pharmaceutical intervention\\], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.\n\n4\\) WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.\n\n5\\) Be a healthy volunteer (n=3) or have a confirmed diagnosis of systemic amyloidosis (n=2) based on either a histologic confirmation with a biopsy containing deposits of apple-green birefringent, Congophilic material with aberrant organ-specific biomarkers indicating amyloid involvement, physical examination, or imaging study.\n\n6\\) Healthy volunteers must also meet inclusion criteria for Part 3. PART 2\n\n1. Understand the study procedures and agree to participate in the study by giving written informed consent.\n2. Be male or female \\>18 years of age.\n3. WOCBP (those who have not been surgically sterilized, are not postmenopausal \\[i.e., last menstrual period \\>2 years ago without pharmaceutical intervention\\], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.\n4. WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.\n5. Have one of the following:\n\n   1. a confirmed diagnosis of systemic AL amyloidosis, based on either a histologic confirmation of a cardiac or extracardiac biopsy containing deposits of apple-green birefringent, Congophilic material AND imaging parameters (ECHO or CMR) indicative of cardiac involvement.\n   2. a confirmed diagnosis of systemic ATTR amyloidosis, based on either a histologic confirmation of a cardiac biopsy containing deposits of apple-green birefringent, Congophilic material or extracardiac biopsy and imaging parameters (ECHO or CMR or 99mTc-PYP) indicative of cardiac involvement, with no evidence of abnormal serum free light chains.\n6. Have a diagnosis of cardiac amyloidosis within 4 years of screening, or longer if contemporaneous clinical data indicates the persistent presence of cardiac amyloidosis.\n\nPART 3\n\n1. Understand the study procedures and agree to participate in the study by giving written informed consent.\n2. Be male or female \\>18 years of age.\n3. WOCBP (those who have not been surgically sterilized, are not postmenopausal \\[i.e., last menstrual period \\>2 years ago without pharmaceutical intervention\\], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.\n4. WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.\n5. Be in good general health, as determined by no clinically significant findings (including Type 2 diabetes mellitus) in the opinion of the Investigator from review of the medical history.\n6. Does not have a diagnosis of amyloidosis nor has a first- or second-degree relative (parent, sibling, child, aunt, uncle, niece, nephew) with confirmed or suspected familial amyloidosis.\n\nPART 4\n\n1. Understand the study procedures and agree to participate in the study by giving written informed consent.\n2. Be male or female \\>18 years of age.\n3. Women of child-bearing potential (those who have not been surgically sterilized, are not postmenopausal \\[i.e., last menstrual period \\>2 years ago without pharmaceutical intervention\\], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.\n4. WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.\n5. Has a confirmed diagnosis of systemic ATTR amyloidosis, based on either a histologic confirmation of a cardiac biopsy containing deposits of apple-green birefringent, Congophilic material or extracardiac biopsy and imaging parameters (ECHO or CMR), or abnormal serum biomarkers indicative of cardiac involvement, with no evidence of abnormal serum free light chains.\n6. Has a diagnosis of cardiac amyloidosis within 4 years of screening, or longer if contemporaneous clinical data indicates the persistent presence of cardiac amyloidosis.\n7. Has a negative 99mTc-PYP imaging study.\n\nExclusion Criteria:\n\nPARTS 1-4\n\n1. Due to annual dosimetry limitations, patients who have participated in another nuclear medicine amyloid imaging clinical trial protocol and received tracer injection in the last 6 months.\n2. Is pregnant or breast-feeding.\n3. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.\n4. Receiving hemodialysis or peritoneal dialysis.\n5. Has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol.\n6. Has any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.\n7. Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within seven (7) days prior to 99mTc-p5+14 administration.\n8. Have previously received any dose of p5+14, in any form.\n9. Have a serum AST \\>2x the upper limit of normal or 80 IU\u002FL AND total bilirubin \\> 1.5x the upper limit of normal or 1.8 mg\u002FdL within the previous six months of enrollment.\n10. Have a serum ALT \\>2x the upper limit of normal or 64 IU\u002FL AND total bilirubin \\> 1.5x the upper limit of normal or 1.8 mg\u002FdL within the previous six months of enrollment.\n11. Have a QTc interval, using Bazett's formula (QTcB) of \\>530 ms, measured within six months prior to enrollment, or assessed prior to injection.",true,"ALL","18 Years",{"count":76,"type":77},31,"ESTIMATED","INTERVENTIONAL",[80],"PHASE1","This study will investigate 99mTc-p5+14, an amyloid-reactive synthetic peptide, p5+14, radiolabeled with technetium-99m, as a radiotracer for detecting paamyloid deposits in patients with AL or ATTR-associated systemic amyloidosis, notably with cardiac involvement.",[83],"Systemic Amyloidosis",[85,86,87,88],"Amyloidosis","p5+14","SPECT imaging","iodine-124-evuzamitide","2026-07-22",{"date":91,"type":92},"2026-07-24","ACTUAL",{"date":94,"type":92},"2023-09-18",{"date":96,"type":77},"2027-06",{"name":5,"class":6},1]