PET Imaging of Subjects Using 124I-PU-AD

Lymphoma Clinical Trial

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

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Lymphoma
• Myeloma
• Solid Malignancy

• NCT number: NCT03371420
• Study type: Interventional
• Source: Samus Therapeutics, Inc.
• Status: Terminated
• Phase: Early Phase 1
• Start date: April 2016
• Completion date: June 10, 2019