Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-02-07 @ 4:31 PM
Study NCT ID:
NCT03371420
Status:
TERMINATED
Last Update Posted:
2023-04-18
First Post:
2017-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET Imaging of Subjects Using 124I-PU-AD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Company has ceased operations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-13', 'studyFirstSubmitDate': '2017-11-29', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC)', 'timeFrame': '1 week'}, {'measure': 'Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax)', 'timeFrame': '1 week'}, {'measure': 'Pharmacokinetic profile of 124I-PU-AD: trough plasma concentration (Cmin)', 'timeFrame': '1 week'}, {'measure': 'Pharmacokinetic profile of 124I-PU-AD: plasma half-life (T1/2)', 'timeFrame': '1 week'}, {'measure': 'Pharmacokinetic profile of 124I-PU-AD: time to maximum plasma concentration (Tmax)', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': '30 days', 'description': 'Safety of 124I-PU-AD in subjects as assessed by evaluation of the incidence, nature, and severity of adverse events and serious adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma', 'Solid Malignancy', 'Alzheimer Disease', 'Myeloma']}, 'referencesModule': {'references': [{'pmid': '34344873', 'type': 'DERIVED', 'citation': 'Bolaender A, Zatorska D, He H, Joshi S, Sharma S, Digwal CS, Patel HJ, Sun W, Imber BS, Ochiana SO, Patel MR, Shrestha L, Shah SK, Wang S, Karimov R, Tao H, Patel PD, Martin AR, Yan P, Panchal P, Almodovar J, Corben A, Rimner A, Ginsberg SD, Lyashchenko S, Burnazi E, Ku A, Kalidindi T, Lee SG, Grkovski M, Beattie BJ, Zanzonico P, Lewis JS, Larson S, Rodina A, Pillarsetty N, Tabar V, Dunphy MP, Taldone T, Shimizu F, Chiosis G. Chemical tools for epichaperome-mediated interactome dysfunctions of the central nervous system. Nat Commun. 2021 Aug 3;12(1):4669. doi: 10.1038/s41467-021-24821-2.'}]}, 'descriptionModule': {'briefSummary': "This is a first in-human, open-label pilot (microdose) study of the positron-emitting agent 124I-PU-AD in subjects with specific cancer types (solid malignancy, lymphoma, and/or myeloma) and/or Alzheimer's disease.", 'detailedDescription': 'This first in-human trial of the positron-emitting agent 124I-PU-AD is an open-label pilot (microdose) study. Up to 10 evaluable subjects who have active disease will be enrolled to evaluate the PK, metabolism, biodistribution, and radiation dosimetry of 124I-PU-AD.\n\nFollowing a 28-day screening period, eligible subjects will return to the clinic on Day 1. A single dose of 124I-PU-AD will be administered by intravenous (IV) injection to subjects.\n\nAfter 124I-PU-AD tracer injection, PET scans will be performed at 4 time points. At each time-point, an axial body image is acquired on a state-of-the-art PET-CT scanner. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point. Serial blood samples will also be obtained at multiple time points.\n\nSubjects will be evaluated to ensure that there are no clinically significant ongoing AEs prior to discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects with a diagnosis of cancer and/or Alzheimer's Disease, meeting trial eligibility criteria as specified below for either disease:\n\n Cancer:\n 1. Subjects with eligible histologic types of cancer. Eligible histologic types of cancer include solid malignancy, myeloma, and lymphoma.\n 2. Cancer histology confirmed by pathology.\n 3. Cancerous disease is radiologically-measurable or evaluable as defined by published tumor response criteria (including but not limited to RECIST 1.1).\n\n Alzheimer's:\n 1. Established diagnosis of mild-moderate Alzheimer's disease based upon neurological and neuropsychological evaluation following the National Institute on Aging - Alzheimer's disease Association criteria that recently revisited the NINCDS-ADRDA criteria.\n 2. Documentation of diagnosis of mild-moderate Alzheimer's disease, as above, by board-certified neurologist.\n2. Subjects who have both cancer and Alzheimer's Disease, subjects are considered eligible if they meet all eligibility requirements for either Alzheimer's Disease or cancer patients, as specified above.\n\nExclusion Criteria:\n\n1. Subject has unacceptable pre-study organ function during screening defined as:\n\n 1. Bilirubin \\> 1.5 x institutional upper limit of normal (ULN)\n 2. AST/ALT \\>2.5 x ULN\n 3. Albumin \\< 2 g/dl\n 4. GGT \\> 2.5 x ULN (IF Alkaline phosphatase \\> 2.5 x ULN)\n 5. Creatinine \\>1.5 x ULN or creatinine clearance \\< 60 mL/min.\n2. Subject has history of acute major illness (i.e., unstable cardiovascular condition.)\n3. Subject has concurrent participation in any interventional studies within 30 days of first dose of study drug."}, 'identificationModule': {'nctId': 'NCT03371420', 'briefTitle': 'PET Imaging of Subjects Using 124I-PU-AD', 'nctIdAliases': ['NCT02751554'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Samus Therapeutics, Inc.'}, 'officialTitle': 'PET Imaging of Subjects Using 124I-PU-AD: A Pilot Study', 'orgStudyIdInfo': {'id': 'PU-AD-00-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '124I-PU-AD', 'description': 'A single dose of 124I-PU-AD will be administered by intravenous (IV) injection', 'interventionNames': ['Drug: PU-AD', 'Device: PET Scan', 'Other: Blood Draws']}], 'interventions': [{'name': 'PU-AD', 'type': 'DRUG', 'armGroupLabels': ['124I-PU-AD']}, {'name': 'PET Scan', 'type': 'DEVICE', 'armGroupLabels': ['124I-PU-AD']}, {'name': 'Blood Draws', 'type': 'OTHER', 'armGroupLabels': ['124I-PU-AD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Robert Morgan, MS, JD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samus Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, {'name': 'Rockefeller University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}