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Clinical Trial · NCT01689636
Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients
Overview
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.
Drug / Compound
EC20
Isotope(s):
TECHNETIUM-99m
Radioisotope: Tc-99m
Theranostic Role: SPECT Imaging
T1/2 (Half-Life): 6 Hours
Decay Mode: GAMMA
Energy: 140 keV (89.1%)
Range: N/A
Decay Daughters: Tc99
Status: FDA Approval: First in 1980’s
Target(s):
- FR (Folate Receptor)
Ligand Class: Small Molecules
Eligibility
Inclusion
- The two subjects with suspected ovarian cancer were to have a known mass. Subjects were to have normal kidney and liver function.
- * All subjects were to be females 18 years of age or older who met the following criteria:
- The four normal subjects were to be normal, as established by medical history, physical examination, and laboratory data, including CBC, serum chemistry, and urinalysis.
- Subjects were to have newly diagnosed, treatment refractory, or recurrent disease. Subjects were to be treatment naïve or at least 2 months since last non-surgical treatment. Subjects were to have normal kidney and liver function.
- The two subjects with obvious advanced stage ovarian cancer were to have either histopathologically proven stage 3 or 4 disease or clinically obvious disease defined by 2 of the following 3 conditions: (1) pelvic mass (2) omental "caking", or (3) ascites.
Exclusion
- Subject was currently taking folic acid supplements and could not stop taking the supplements for a period of 3 days (2 days prior to the study and one day after last imaging procedure).
- Subject was pregnant or breast-feeding.
- Subject was simultaneously participating in another investigative drug or device study, or had completed follow-up phase of any previous study within 30 days prior to enrollment in this study.
- * The following subjects were to be excluded:
- Subject had a known history of chronic abuse of drugs or alcohol or had tested positive in the pre-study urine drug abuse screen.
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