- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01689662
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Suspected Metastatic Renal Cell Carcinoma
A Multi-center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Suspected Metastatic Renal Cell Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted diagnostic radiopharmaceutical 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.
Endocyte's folate-targeted delivery system was applied towards the targeting of a diagnostic imaging agent (111In-DTPA-Folate) to ovarian cancer tumors. This proof-of-principle study was designed to demonstrate the ability of folate to target drugs to folate-receptor-positive (FR+) cancer tissue.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 metastatic renal cell carcinoma with at least one target lesion as identified 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, excluding the follow-up phase.
- Subject has received an investigational agent within 7 days prior to enrollment.
- 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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tc 99m EC20
Subjects will receive two intravenous injections 1-3 minutes apart:
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Technetium Tc 99m-ethylenedicysteine
Other Study ID Numbers
- EC20.3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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