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Sponsored by: |
Wilex |
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 |
MedlinePlus related topics: | Cancer Kidney Cancer |
Drug Information available for: | Iodine Cadexomer iodine Rencarex |
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: | November 2008 (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: Silke Treutner | +49 89 413 138 ext 83 | silke.treutner@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 | |||||
Brigham and Women's Hospital | Recruiting | ||||
Boston, Massachusetts, United States, 02115 | |||||
Sub-Investigator: Richie Jerome, MD | |||||
Beth Israel Deaconess Hosptial | Recruiting | ||||
Boston, Massachusetts, United States, 02215 | |||||
Sub-Investigator: Michael Atkins, MD | |||||
Lahey Clinic | Recruiting | ||||
Burlington, Massachusetts, United States, 01805 | |||||
Principal Investigator: John Libertino, MD | |||||
Dana-Farber Cancer Institute | Recruiting | ||||
Boston, Massachusetts, United States, 02115 | |||||
Principal Investigator: Annick Van den Abbeele, 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 | |||||
Columbia Presbyterian Medical Center | Recruiting | ||||
New York, New York, United States, 10032 | |||||
Principal Investigator: James McKiernan, 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 | Not yet recruiting | ||||
Houston, Texas, United States, 77030-4009 | |||||
Principal Investigator: Christopher Wood, MD |
Wilex |
Principal Investigator: | Chaitanya Divgi, MD | University of Pennsylvania |
Responsible Party: | Wilex ( Silke Treutner ) |
Study ID Numbers: | WX/20-001 |
First Received: | January 21, 2008 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00606632 |
Health Authority: | United States: Food and Drug Administration |
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