CLINICAL STUDY OF A SINGLE-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND BIODISTRIBUTION OF TECHNETIUM Tc 99m EC20 IN NORMAL VOLUNTEERS AND OVARIAN CANCER PATIENTS
This was a single-center, open-label evaluation of a single injection of Tc 99m EC20
containing 0.1 mg EC20 labeled with 15 - 20 mCi of technetium-99m in normal volunteers and
patients with known or suspected ovarian cancer. Two normal volunteers and two patients
also were to receive an injection of 0.25 - 2.0 mg folic acid 1 to 2 minutes prior to the
injection of Tc 99m EC20. Serial blood samples and urine were collected during the 24-hour
period following each injection for pharmacokinetic evaluation. Serial whole body images
were acquired during the 24-hour postdose period for dosimetry evaluations. Safety was
monitored through predose and postdose physical examinations, electrocardiograms (ECGs),
vital signs and clinical laboratory evaluations. Adverse events were monitored from the
time of signing of Informed Consent to 24 hours postdose.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Determine the biodistribution and excretion of the radioactive drug substance (Technetium Tc 99m EC20) and estimate the radiation absorbed dose
24 hours
No
United States: Food and Drug Administration
EC20.1
NCT01689636
August 2000
July 2002
Name | Location |
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Washington University Medical Center | Saint Louis, Missouri 63105 |