PET Imaging of Subjects Using 124I-PU-AD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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PET Imaging of Subjects Using 124I-PU-AD: A Pilot Study

Conditions
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Lymphoma, Solid Malignancy, Alzheimer Disease, Myeloma

Intervention / Treatment
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* Drug: PU-AD
* Device: PET Scan
* Other: Blood Draws


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with a diagnosis of cancer and/or Alzheimer's Disease, meeting trial eligibility criteria as specified below for either disease: Cancer: Subjects with eligible histologic types of cancer. Eligible histologic types of cancer include solid malignancy, myeloma, and lymphoma. Cancer histology confirmed by pathology. Cancerous disease is radiologically-measurable or evaluable as defined by published tumor response criteria (including but not limited to RECIST 1.1). Alzheimer's: 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. Documentation of diagnosis of mild-moderate Alzheimer's disease, as above, by board-certified neurologist. 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. Exclusion Criteria: Subject has unacceptable pre-study organ function during screening defined as: Bilirubin > 1.5 x institutional upper limit of normal (ULN) AST/ALT >2.5 x ULN Albumin < 2 g/dl GGT > 2.5 x ULN (IF Alkaline phosphatase > 2.5 x ULN) Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min. Subject has history of acute major illness (i.e., unstable cardiovascular condition.) Subject has concurrent participation in any interventional studies within 30 days of first dose of study drug.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 124I-PU-AD<br>A single dose of 124I-PU-AD will be administered by intravenous (IV) injection | Drug: PU-AD<br> <br> Device: PET Scan<br> <br> Other: Blood Draws<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC) |  | 1 week | 
| Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax) |  | 1 week | 
| Pharmacokinetic profile of 124I-PU-AD: trough plasma concentration (Cmin) |  | 1 week | 
| Pharmacokinetic profile of 124I-PU-AD: plasma half-life (T1/2) |  | 1 week | 
| Pharmacokinetic profile of 124I-PU-AD: time to maximum plasma concentration (Tmax) |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Safety of 124I-PU-AD in subjects as assessed by evaluation of the incidence, nature, and severity of adverse events and serious adverse events. | 30 days |