Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG-Nanodosing: the Path to Higher Sensitivity and Lower Toxicity Radiopharmaceuticals
The goal of this proposal is to produce and test high specific activity Ultratrace
iobenguane I 123 in normal human volunteers. The low specific activity iobenguane I 123 has
been shown to be useful for the detection and staging of neuroendocrine tumors in adults and
children and imaging neuronal activity in the heart. The innovation in this proposal is
through the use of patented solid phase technology to produce a proven diagnostic agent at
extremely high specific activity to increase sensitivity and specificity and lower radiation
exposure to normal organs without the pharmacologically active cold carrier compound. The
FDA considers iobenguane labeled with two different isotopes of iodine [I-131 and I-123] as
two distinct drugs requiring distinct regulatory applications.
To meet the required quality standards for the chemistry, manufacturing and controls
component of an IND application, GMP quality polymer drug precursor is used to generate the
Ultratrace diagnostic iodine-123 agent. Analytical methods were validated with the
proposed final drug formulation to demonstrate the final drug does not interfere with tests
used to define the identity, purity, and strength of the agent. The drug product was
verified for apyrogenicity and sterility before human testing. The IND application was
written and submitted to the FDA and the Duke Medical Center IRB. MIP produces clinical
trial material, and will conduct human testing of the radioactive drug substance for safety
and superiority compared to conventional iobenguane I 123 in normal healthy volunteers.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Radiation dosimetry was measured by imaging at several time points. Blood and urine samples were also collected to correlate with imaging parameters. Side effects were also assessed after drug administration.
Bennett B Chin, MD
United States: Food and Drug Administration
|Duke University Medical Center||Durham, North Carolina 27710|