A Phase II Clinical Study to Evaluate the Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor
Tc 99m EC20
Urogenital Diseases+27
+ Genital Diseases
+ Urinary Bladder Diseases
Other Study
Summary
Study start date: August 1, 2003
Actual date on which the first participant was enrolled.This Phase II, limited institution, open-label, single-arm, baseline-controlled study is designed to obtain data on the percentage of patients with recurrent or metastatic cancer from a solid tumor (including, but not limited to, breast, lung, mesothelioma, liver, colorectal, prostate, head and neck, pancreas, bladder and testicular cancer) with increased uptake of FalateScan in tumors, correlate the immunohistochemical staining findings with the FolateScan images, and verify product safety in patients with suspected recurrent or metastatic disease from any solid tumor.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 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: Patients must meet the following eligibility requirements to be enrolled in the study: Patient must be 18 years of age or older. Patient must have known or strongly suspected recurrent or metastatic cancer from a solid tumor with at least one identifiable lesion > 1.5 cm as diagnosed by conventional imaging. Patient must have adequate kidney function defined as serum creatinine of < 1.5 X ULN. Patient must have adequate liver function defined as transaminases (SGOT and/or SGPT) may be up to 2.5 X ULN if alkaline phosphatase is <ULN or alkaline phosphatase may be up to 2.5 X ULN if Transaminases are < ULN. If alkaline phosphatase is outside of these parameters and is due to bone metastases verified by assessment of isoenzymes, then the subject is eligible. Patient must provide written informed consent prior to enrollment. Exclusion Criteria: Patients must be excluded in any of the following conditions are present: 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 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