Trial Information
A Pilot and Feasibility Study Of The Imaging Potential Of EC17 In Subjects Undergoing Surgery Presenting With Renal Nodules
Inclusion Criteria:
1. Adult patients 18 years of age or older
2. Patients presenting with a renal cell nodule or mass that are scheduled for open
resection based on clinical criteria
3. Good operative candidate
4. Subject capable of giving informed consent and participating in the process of
consent.
Exclusion Criteria:
1. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin
(hCG) test within 72 hours of surgery
2. Patients with a history of anaphylactic reactions to Folate-FITC or insects
3. At-risk patient populations
1. People who would be easily lost to follow-up (ex: People who are homeless or
alcohol dependent)
2. Children and neonates
3. Patients unable to participate in the consent process
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
The ability of the imaging system to detect the expression of EC17 in the nodule/mass (i.e. tumor) and discern the uptake of the dye by the tumor
Outcome Time Frame:
Within two hours of injection of the EC17
Safety Issue:
No
Principal Investigator
Sunil Singhal, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Pennsylvania
Authority:
United States: Food and Drug Administration
Study ID:
EC17 Renal Cell
NCT ID:
NCT01778933
Start Date:
May 2013
Completion Date:
Related Keywords:
- Renal Cell Carcinoma
- Renal cell carcinoma
- Renal nodules
- Carcinoma
- Carcinoma, Renal Cell
Name | Location |
Hospital of the University of Pennsylvania |
Philadelphia, Pennsylvania 19104 |