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Sponsored by: |
Wilex |
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Information provided by: | Wilex |
ClinicalTrials.gov Identifier: | NCT00606632 |
This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses.
Condition | Intervention | Phase |
---|---|---|
Renal Cell Carcinoma Kidney Cancer |
Drug: 124-Iodine-cG250 (124I-cG250) |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Comparative Study of PET/CT Versus Diagnostic CT for the Detection of Clear Cell Renal Cell Carcinoma in Pre-Surgical Patients With Renal Masses Using Iodine-124 Labeled Chimeric G250 (124I-cG250) |
Estimated Enrollment: | 166 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
A preoperative 124I-cG250 PET scan may distinguish between clear cell and non-clear cell renal carcinoma in patients with renal masses. Studies of imaging characteristics of 124I by a variety of PET cameras, quantification of tumor uptake of 124I-labeled antibody and correlation with biopsy measurement of tumor and normal tissue have met with encouraging results. As clear cell renal cancers are associated with an aggressive phenotype their a priori determination may help guide appropriate surgical/therapeutic management.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following laboratory results should be within the following limits within the last 2 weeks prior to study day 1:
Exclusion Criteria:
Contact: Roman Bartz, Dr. | +49 89 413 138 ext 52 | roman.bartz@wilex.com |
United States, California | |
David Geffen School of Medicine, UCLA | Recruiting |
Los Angeles, California, United States, 90095-1721 | |
Principal Investigator: Allan Pantuck, MD | |
Stanford University Medical Center | Recruiting |
Stanford, California, United States, 94305 | |
Principal Investigator: Benjamin Chung, MD | |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Center | Recruiting |
Tampa, Florida, United States, 33612 | |
Principal Investigator: Wade Sexton, MD | |
United States, Massachusetts | |
Lahey Clinic | Recruiting |
Burlington, Massachusetts, United States, 01805 | |
Principal Investigator: John Libertino, MD | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109-0330 | |
Principal Investigator: Khaled Hafez, MD | |
United States, Nevada | |
Nevada Cancer Institute | Recruiting |
Las Vegas, Nevada, United States, 89135 | |
Principal Investigator: Nicholas Vogelzang, MD | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Principal Investigator: Steven Larson, MD | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27711 | |
Principal Investigator: Thomas Polascik, MD | |
UNC School of Medicine-Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Principal Investigator: Arif Sheikh, MD | |
United States, Ohio | |
Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Principal Investigator: Steve Campbell, MD | |
Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 | |
Principal Investigator: Robert Bahnson, MD | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Principal Investigator: Daniel Pryma, MD | |
Fox Chase Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Principal Investigator: David Chen, MD | |
United States, Texas | |
MD Anderson | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Principal Investigator: Christopher Wood, MD |
Principal Investigator: | Chaitanya Divgi, MD | University of Pennsylvania |
Responsible Party: | Wilex ( Roman Bartz ) |
Study ID Numbers: | WX/20-001 |
Study First Received: | January 21, 2008 |
Last Updated: | June 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00606632 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Renal Mass Clear Cell Renal Cell Carcinoma Cancer of Kidney Kidney Cancer Neoplasms cG250 |
antibody, monoclonal Iodine 124 Positron-Emission Tomography Kidney Renal Cancer Renal Neoplasms |
Anti-Infective Agents Urinary Tract Neoplasm Kidney Cancer Trace Elements Urogenital Neoplasms Urologic Neoplasms Carcinoma Antibodies, Monoclonal Anti-Infective Agents, Local Antibodies Renal Cancer |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Clear Cell Renal Cell Carcinoma Iodine Micronutrients Kidney Diseases Adenocarcinoma Immunoglobulins Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Growth Substances Physiological Effects of Drugs Trace Elements Urogenital Neoplasms Urologic Neoplasms Pharmacologic Actions Carcinoma Anti-Infective Agents, Local Neoplasms |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Carcinoma, Renal Cell Iodine Micronutrients Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |