A Screening Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma
Technetium Tc 99m EC20
Urogenital Diseases+13
+ Adenocarcinoma
+ Carcinoma
Other Study
Summary
Study start date: November 1, 2003
Actual date on which the first participant was enrolled.The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted diagnostic radiopharmaceutical agent designed to bind to the folate receptor. The folate receptor is a glycoprotein that is over-expressed in many types of cancer cells but it is only minimally distributed in normal tissues . Folate conjugates bind to the folate receptor with high affinity and are brought into the cell via endocytosis. In contrast, folic acid itself enters most normal cells via the reduced folate carrier, a pathway entirely inaccessible to folate conjugates. Therefore, these folate conjugates are specific to cancer cells. This is a phase 2, multi-center, open-label, single-treatment group, baseline-controlled study designed to verify product safety, gather data on the percentage of metastatic renal cell carcinoma patients with increased uptake of FolateScan in tumors, and to calculate sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared to immunohistochemical staining (IHC).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.150 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.Any sex
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: To be eligible for the study, patients must fulfill all of the following criteria: Patient must be 18 years of age or older. Patient must have suspected metastatic renal cell carcinoma with at least one identifiable lesion >2.0 cm as diagnosed by CT, MRI, or ultrasonography within 60 days prior to enrollment. Patient must have good kidney function defined as a serum creatinine ≤1.5 X ULN. Patient must provide written informed consent prior to enrollment. Patients must provide a formalin-fixed, paraffin-embedded tissue sample of either the primary or metastatic or recurrent site(s) for IHC staining for the presence of folate receptors from either a previous surgical/biopsy procedure or from a surgery/biopsy scheduled within 30 days of FolateScan. A fine needle aspirate is not acceptable. Exclusion Criteria: Any of the following criteria will make the patient ineligible to participate in this study: Patient is pregnant or breastfeeding. Patient is simultaneously participating in another investigational drug study, excluding the follow-up phase. Patient has received an investigational agent or therapeutic chemotherapy within 7 days prior to enrollment. Patient is unable to tolerate conditions for radionuclide imaging. Patient 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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Baylor College of Medicine
Houston, United States