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A Pilot and Feasibility Study Of The Imaging Potential Of EC17 In Subjects Undergoing Surgery Presenting With Renal Nodules


Phase 0
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

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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