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Pilot and Feasibility Study of the Imaging Potential of EC17

Phase 1
18 Years
Open (Enrolling)
Lung and Pleural Malignancies, Neoplasms, Nodules

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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

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:


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:


Principal Investigator

Sunil Singhal, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania


United States: Food and Drug Administration

Study ID:

EC17 Lung Cancer



Start Date:

April 2012

Completion Date:

Related Keywords:

  • Lung and Pleural Malignancies
  • Neoplasms
  • Nodules
  • Neoplasms



Hospital of the University of Pennsylvania Philadelphia, Pennsylvania  19104