Trials / Completed
CompletedNCT00606632
Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 226 (actual)
- Sponsor
- Heidelberg Pharma AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 124-Iodine-cG250 (124I-cG250) | i.v. and PET/CT scan 4+/-2 days after administration |
| PROCEDURE | CT | contrast enhanced CT scan |
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2009-11-01
- Completion
- 2009-12-01
- First posted
- 2008-02-04
- Last updated
- 2018-10-02
- Results posted
- 2014-04-14
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00606632. Inclusion in this directory is not an endorsement.