Folatescan Safety and Efficacy Evaluation in Ovarian and Endometrial Carcinoma
Tc 99m EC20
Urogenital Diseases+15
+ Genital Diseases
+ Adnexal Diseases
Other Study
Summary
Study start date: August 1, 2003
Actual date on which the first participant was enrolled.This phase 2, two-center, open-label, single-treatment group, within-patient-controlled study was conducted to: Expand the safety database and gather data on the percentage of patients with known or suspected ovarian carcinoma or recurrent endometrial carcinoma who show increased uptake of FolateScan in tumors (primary objective). Calculate the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared with immunohistochemical (IHC) staining (secondary objective).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.16 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Subjects must meet the following eligibility requirements to be enrolled in the study. Subject must be 18 years of age or older. Subject must have known or strongly suspected ovarian carcinoma or recurrent endometrial carcinoma with at least one identifiable lesion > 1.5 cm as diagnosed by ultrasonography, MRI, or CT. Subject must have good kidney function. Subject must provide written informed consent prior to enrollment. Exclusion Criteria: Subjects must be excluded if any of the following conditions are present: Subject is pregnant or breastfeeding. Subject is simultaneously participating in another investigational drug study. Subject has completed the follow-up phase of any previous study less than 30 days prior to enrollment in this study. Subject is unable to tolerate conditions for radionuclide imaging. Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimental