[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05951816":3,"trial-entities:NCT05951816":93,"trial-summary:NCT05951816":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":46,"secondary_outcomes":51,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":87,"overall_officials":89,"references":91,"see_also_links":92},"NCT05951816","UTGSM-164388-101","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","RECRUITING","2027-06","2026-07","2026-07-24","2023-09-18","University of Tennessee Graduate School of Medicine","OTHER",false,"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.","The University of Tennessee Graduate School of Medicine (UTGSM) is investigating 99mTc-p5+14, an amyloid-reactive synthetic peptide, p5+14, radiolabeled with technetium-99m, as a radiotracer for planar gamma scintigraphy (PGS), single photon emission computed tomography (SPECT) or SPECT with x-ray computed tomography (SPECT\u002FCT) for the diagnosis of systemic amyloidosis, notably with cardiac involvement. Based on nonclinical data and clinical data of 124I-p5+14 from Study AMY1001, peptide p5+14 binds many types of human amyloid and is rapidly cleared from the central compartment. When radiolabeled with 99mTc, p5+14 may enable visualization of amyloid laden tissues and organs by SPECT\u002FCT imaging or PGS. Thus, this study has been designed to evaluate the dosimetry and biodistribution of 99mTc-p5+14 in patients with systemic amyloidosis compared with the biodistribution in healthy volunteers.",[19],"Systemic Amyloidosis",[21,22,23,24],"Amyloidosis","p5+14","SPECT imaging","iodine-124-evuzamitide","INTERVENTIONAL","DIAGNOSTIC",[28],"PHASE1",{"count":30,"type":31},31,"ESTIMATED",[33,40],{"type":34,"name":35,"description":36,"armGroupLabels":37},"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.",[38,39],"Biodistribution in patients with systemic AL or ATTR amlyoidosis","Estimation of dosimetry for 99mTc-p5+14 and Biodistribution Of 99mtc-p5+14 In Healthy Subjects",{"type":34,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"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.",[38],[45],"99mTc-PYP",[47],{"measure":48,"description":49,"timeFrame":50},"Whole body effective dosimetry measurement","Whole body effective radiation dose assessed from analysis of organ-specific radioactivity uptake in planar and SPECT images.","From enrollment to the end of study is 8 days",[52,55],{"measure":53,"description":54,"timeFrame":50},"Measure cardiac uptake of 99mTc-p5+14 radioactivity from planar and SPECT\u002FCT images in comparison to 99mTc-PYP uptake","Measurement of 99mTc-p5+14 uptake in the heart of healthy volunteers and patients with systemic AL or ATTR amyloidosis and comparison with contemporaneous 99mTc-PYP cardiac radioactivity.",{"measure":56,"description":57,"timeFrame":50},"Measure uptake of 99mTc-p5+14 radioactivity in extracardiac tissues from planar and SPECT\u002FCT images","Measurement of 99mTc-p5+14 radioactivity in abdominothoracic organs of healthy volunteers and patients with systemic AL or ATTR amyloidosis from planar and SPECT\u002FCT images.","ALL","18 Years",null,true,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"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.",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":13,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":84},"Knoxville","Tennessee","37920","United States",[76,81],{"name":77,"role":78,"phone":79,"email":80},"Emily B Martin, PhD","CONTACT","865-305-9533","emartin@utmck.edu",{"name":82,"role":83},"Jonathan S Wall, PhD","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},35.96064,-83.92074,[88],{"name":77,"role":78,"phone":79,"email":80},[90],{"name":82,"affiliation":13,"role":83},[],[],{"nct_id":4,"conditions":94,"biomarkers":97},[95,96],"Healthy Volunteers","Systemic amyloidosis",[],{"nct_id":4,"found":61,"summary":99,"prompt_version":109},{"design":100,"status":101,"heading":102,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is an interventional study involving up to 31 participants. It will include both healthy volunteers and patients with systemic amyloidosis.","completed","Phase 1 Study of 99mTc-p5+14 for Systemic Amyloidosis","This study is testing a new imaging agent called 99mTc-p5+14. This agent is designed to help doctors see amyloid deposits in your body, especially in the heart, using special scans (like SPECT\u002FCT). Amyloidosis is a condition where abnormal proteins called amyloid build up in organs. Researchers want to see how 99mTc-p5+14 moves through the body in healthy volunteers and in people with AL or ATTR systemic amyloidosis. They will also compare it to another imaging agent, 99mTc-Pyrophosphate, which is already used to diagnose heart-related ATTR amyloidosis. The main goal is to understand how much radiation exposure you would receive from 99mTc-p5+14. This study is looking for up to 31 participants, including adults aged 18 and older. The current status of the study is unclear.","Participants will be followed for 8 days after enrollment to measure whole body effective dosimetry.",124,"The study involves measurements of radiation exposure from enrollment to 8 days after the start of the study.","Not stated in the trial record.",[41],"v2"]