Trial Information
Pilot and Feasibility Study of the Imaging Potential of EC17
Inclusion Criteria:
1. Adult patients over 18 years of age
2. Patients presenting with a lung or pleural nodule or mass presumed to be resectable
on pre-operative assessment
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) within 72 hours of surgery
2. Patients with a history of anaphylactic reactions to Folate-FITC or insects
3. At-risk patient populations
1. Homeless patients
2. Patients with drug or alcohol dependence
3. Children and neonates
4. 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 Lung Cancer
NCT ID:
NCT01778920
Start Date:
April 2012
Completion Date:
Related Keywords:
- Lung and Pleural Malignancies
- Neoplasms
- Nodules
- Neoplasms
Name | Location |
Hospital of the University of Pennsylvania |
Philadelphia, Pennsylvania 19104 |