PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT01269593|
Recruitment Status : Recruiting
First Posted : January 4, 2011
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma Myeloma Active Solid Malignancy||Drug: PET Imaging using 124 IPUH71||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study|
|Actual Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: PET Imaging Using 124 IPUH71
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.
Drug: PET Imaging using 124 IPUH71
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.
- To study the pharmacokinetics [ Time Frame: 2 years ]of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma.
- To study the metabolism [ Time Frame: 2 years ]of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.
- To study the biodistribution [ Time Frame: 2 years ]of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.
- To study the radiation dosimetry [ Time Frame: 2 years ]of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269593
|Contact: Mark Dunphy, DO||212-639-8131|
|Contact: Gabriela Chiosis, PhD||646-888-2235|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Mark Dunphy, DO 212-639-8131|
|Contact: Gabriela Chiosis, PhD 646-888-2235|
|Principal Investigator: Mark Dunphy, DO|
|Principal Investigator:||Mark Dunphy, DO||Memorial Sloan Kettering Cancer Center|