Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-24 @ 2:31 PM
Study NCT ID:
NCT01269593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-14
First Post:
2010-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2010-12-29', 'studyFirstSubmitQcDate': '2011-01-03', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study the pharmacokinetics', 'timeFrame': '2 years', 'description': 'of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma.'}], 'secondaryOutcomes': [{'measure': 'To study the metabolism', 'timeFrame': '2 years', 'description': 'of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.'}, {'measure': 'To study the biodistribution', 'timeFrame': '2 years', 'description': 'of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.'}, {'measure': 'To study the radiation dosimetry', 'timeFrame': '2 years', 'description': 'of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.'}]}, 'conditionsModule': {'keywords': ['PET Scan', '124I-PUH71', '10-139'], 'conditions': ["Non-Hodgkin's Lymphoma", 'Myeloma', 'Active Solid Malignancy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see how a new drug, named PUH71, accumulates in the different parts of the body \\& inside tumors and how long PUH71 lasts in the blood, when given to study participants in tiny amounts. The results of this study will help researchers (1) plan how they will use PUH71 as an experimental new drug (at much-higher doses) for the treatment of cancer, in clinical trials; and (2) know whether PUH71 might be used as a drug for detecting tumors with scanner machines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma (histology confirmed by MSKCC Department of Pathology)\n* Disease is measurable or evaluable as defined by RECIST (1.1 or original version) or other tumor response criteria from an MSKCC IRB-approved clinical research protocol.\n* This does not apply to patients with myeloproliferative neoplasm. The presence of active myeloproliferative neoplasm will be determined by applicable disease specific diagnostic criteria and patient assessment by the patient's oncologist and trial investigators (eg, manifestations of active MPN such as splenomegaly, abnormal blood counts, etc).\n* Age between 18-90\n* Negative serum pregnancy test for females of childbearing age (11-55 years) and/or lack child-bearing potential\n* No breast-feeding\n\nExclusion Criteria:\n\n* Previous allergic reaction to contrast medium.\n* Hypersensitivity to iodide products.\n* Known hyperthyroidism\n\nHepatic:\n\n* Bilirubin \\> 1.5 x institutional upper limit of normal (ULN)\n* AST/ALT \\>2.5 x ULN\n* Albumin \\< 2 g/dl\n* GGT \\> 2.5 x ULN IF Alkaline phosphatase \\> 2.5 x ULN. Renal: Creatinine \\>1.5 x ULN or creatinine clearance \\< 60 mL/min.\n* Positive serum pregnancy test for females\n* Acute major illness (e.g., infection, unstable cardiovascular condition, etc.)"}, 'identificationModule': {'nctId': 'NCT01269593', 'briefTitle': 'PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study', 'orgStudyIdInfo': {'id': '10-139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PET Imaging Using 124 IPUH71', 'description': 'Patients will receive an injection of up to 11.0 mCi (range: 4.0-11.0 mCi) of 124I-PUH71, followed by serial PET scanning and blood draws, over a period of 3 days. Optional with a fourth day of PET scanning is to be pursued, in willing patients.', 'interventionNames': ['Drug: PET Imaging using 124 IPUH71']}], 'interventions': [{'name': 'PET Imaging using 124 IPUH71', 'type': 'DRUG', 'otherNames': ['Blood will be drawn at the multiple time points for pharmacokinetic & metabolite', 'analyses of 124I-PUH71. We anticipate these time points to be: approximately 10', 'minutes, 20 minutes, 30 minutes, 1-2 H, and 3-4 H, post-injection. Blood', 'samples will be obtained in the PET imaging suite.'], 'description': 'A dose of up to 11.0 mCi (range: 4.0-11.0 mCi) of 124I-PUH71 will be administered intravenously with the patient at rest. 124I-PUH71 scans will be performed at immediately and/or 3-4 hours, 20-24 hours, and 40-80 hours after injection of the radiotracer. Optionally, in willing patients scans will be performed 160-200 hours (\\~7-8 days) after injection of the radiotracer. At each time-point, a 45-60 minute axial body image is acquired. Images will be 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. A 30-45 minute scanning timeperiod is typical for clinical PET studies.', 'armGroupLabels': ['PET Imaging Using 124 IPUH71']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mark Dunphy, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Samus Therapeutics', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}