Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients
Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four subjects with known or suspected ovarian cancer.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||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|
- Determine the biodistribution and excretion of the radioactive drug substance (Technetium Tc 99m EC20) and estimate the radiation absorbed dose [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||August 2000|
|Study Completion Date:||July 2002|
Experimental: Single-center, open-label
The study was designed as a single-center, open-label clinical study to evaluate the safety, pharmacokinetics, dosimetry and metabolism of Tc 99m EC20 in normal volunteers and in patients with known or suspected ovarian cancer.
Eight subjects were to be enrolled at one center: four normal subjects, four patients with ovarian cancer. Each subject was to receive a single injection of Tc 99m EC20 complex composed of 0.1 mg ligand (EC20) and 15 - 20 mCi of Tc 99m. Two (2) of the 4 normal subjects and 2 of the 4 patients were to receive an injection of 0.25-2.0 mg folic acid 1-2 minutes prior to the injection of Tc 99m EC20.
|Drug: Tc 99m EC20|
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.