PET Imaging of Subjects Using 124I-PU-AD
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|ClinicalTrials.gov Identifier: NCT03371420|
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : June 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Solid Malignancy Alzheimer Disease Myeloma||Drug: PU-AD Device: PET Scan Other: Blood Draws||Early Phase 1|
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.
Following 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.
After 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.
Subjects will be evaluated to ensure that there are no clinically significant ongoing AEs prior to discharge.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PET Imaging of Subjects Using 124I-PU-AD: A Pilot Study|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||June 10, 2019|
|Actual Study Completion Date :||June 10, 2019|
A single dose of 124I-PU-AD will be administered by intravenous (IV) injection
Device: PET Scan
Other: Blood Draws
- Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC) [ Time Frame: 1 week ]
- Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax) [ Time Frame: 1 week ]
- Pharmacokinetic profile of 124I-PU-AD: trough plasma concentration (Cmin) [ Time Frame: 1 week ]
- Pharmacokinetic profile of 124I-PU-AD: plasma half-life (T1/2) [ Time Frame: 1 week ]
- Pharmacokinetic profile of 124I-PU-AD: time to maximum plasma concentration (Tmax) [ Time Frame: 1 week ]
- Incidence of adverse events [ Time Frame: 30 days ]Safety of 124I-PU-AD in subjects as assessed by evaluation of the incidence, nature, and severity of adverse events and serious adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371420
|United States, New York|
|Memorial Sloan Kettering|
|New York, New York, United States, 10065|
|Study Director:||Robert Morgan, MS, JD||Sponsor GmbH|