Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-28 @ 5:42 PM
Study NCT ID:
NCT01337466
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
2011-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biodistribution and Dosimetry Evaluation of [124I]FIAU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016459', 'term': 'Prosthesis-Related Infections'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C043457', 'term': 'fialuridine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-26', 'studyFirstSubmitDate': '2011-04-08', 'studyFirstSubmitQcDate': '2011-04-15', 'lastUpdatePostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the biodistribution and dosimetry evaluation of [124I]FIAU', 'timeFrame': '72 hrs', 'description': 'Subjects will be dosed with \\[124I\\]FIAU at Time 0 on Day 0, and a PET-CT scan will be conducted immediately after the injection. Imaging will be repeated at 2 hours, 4 hours, 6 hours, 24 hours, 48 hours, and 72 hours after dosing.\n\nAll images generated will be reviewed for biodistribution and dosimetry.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the safety and tolerability of [124I]FIAU', 'timeFrame': '28 +/- 2 days', 'description': 'Safety will be monitored throughout the study for all subjects. Safety will be assessed by monitoring of adverse events and vital signs, clinical laboratory tests including LFTs, lactate, serum chemistry and CBC, physical examination, and 12-lead ECG.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase I', 'FIAU', 'Fialuridine', 'Biodistribution', 'Dosimetry', 'Prosthetic', 'Joint', 'Infection', 'PET-CT'], 'conditions': ['Prosthesis Related Infections']}, 'descriptionModule': {'briefSummary': 'This protocol will evaluate the biodistribution and dosimetry of \\[124I\\]FIAU in both healthy volunteers and patients with prosthetic joint infections. This pilot study will also investigate the safety and tolerability of \\[124I\\]FIAU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "The following are the main inclusion criteria for all subjects:\n\n1. Males or females age \\> 18 years\n2. Informed consent\n3. Subjects with chronic medical conditions such as hypertension and diabetes should be considered stable by the principal investigator\n4. Women should be postmenopausal or surgically sterile\n5. Able to return for all study assessments\n\nIn addition, the following main inclusion criteria apply for subjects with suspected prosthetic joint infection:\n\n1. Operative intervention planned in the 30 days following study enrollment\n2. Prosthetic joint implant in site for more than 3 months prior to enrollment\n\nThe following are the main exclusion criteria for all subjects:\n\n1. Unable to comply with study requirements\n2. Indication in the opinion of the principal investigator for surgery within 48 hours of presentation.\n3. Receipt of any antibiotic therapy in the 2 weeks preceding imaging\n4. Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, s/p organ transplantation, receipt of steroids for \\> 10 days at \\> 10 mg of prednisone equivalent daily within the 90 days prior to enrollment\n5. Requirement for any medication that predisposes to lactic acidosis (e.g., metformin, iron, isoniazid and salicylates; see Appendix A)\n6. Requirement for any medication that has potential mitochondrial toxicity, e.g., nucleoside analogues (zidovudine, didanosine, stavudine)\n7. History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy, neuropathy, ataxia, retinitis pigmentosa and ptosis \\[NARP\\], myoneurogenic gastrointestinal encephalopathy \\[MNGIE\\], myoclonic epilepsy with ragged red fibers \\[MERFF\\] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome \\[MELAS\\]\n8. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n9. Pre-existing myopathy or neuropathy\n10. Abnormal liver function tests defined as alanine aminotransferase (ALT) \\> the upper limit of normal (ULN), aspartate aminotransferase (AST) \\> ULN, gamma glutamyl transferase (GGT) \\> ULN\n11. Alcohol use \\> 3 units per day in men or 2 units per day in women or active intravenous drug use\n12. Creatinine clearance \\< 30 mL/min\n13. Body mass index \\> 40\n14. Life expectancy \\< 6 months\n15. Hypersensitivity to iodine"}, 'identificationModule': {'nctId': 'NCT01337466', 'briefTitle': 'Biodistribution and Dosimetry Evaluation of [124I]FIAU', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioMed Valley Discoveries, Inc'}, 'officialTitle': 'Biodistribution and Dosimetry of [124i]FIAU in Patients With Prosthetic Joint Infection of The Knee or Hip and Healthy Subjects Using PET-CT Scanning', 'orgStudyIdInfo': {'id': 'BVD001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[124I]FIAU', 'description': 'single dose study of \\[124I\\]FIAU in healthy volunteers or subjects with prosthetic joint infection who will undergo PET-CT scanning', 'interventionNames': ['Radiation: [124I]FIAU']}], 'interventions': [{'name': '[124I]FIAU', 'type': 'RADIATION', 'otherNames': ['Fialuridine'], 'description': 'This is a single dose study of 2 mCi \\[124I\\]FIAU in healthy volunteers or subjects with prosthetic joint infection of the knee or hip who will undergo serial PET-CT scanning.', 'armGroupLabels': ['[124I]FIAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sinai Hospital of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore long Island Jewish Medical Center', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}], 'overallOfficials': [{'name': 'Michael A Mont, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sinai Hospital of Baltimore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioMed Valley Discoveries, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}