Pilot and Feasibility Study of the Imaging Potential of EC17: Intraoperative Folate-fluorescein Conjugate (EC17) Lung Cancer (CA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01778920
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : May 17, 2016
VA Office of Research and Development
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

The goal of this study is to perform imaging of patient's tumors while the chest is open and the tumor is being removed.

According to the World Health Organization, lung cancer is the most common cause of cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide annually as of 2004. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismal 53% for Stage I and 32% for Stage II. The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through imaging during surgery it would be possible for us to improve the rates of recurrence free patients and thus overall survival.

Thoracic malignancies are the ideal disease to investigate intra-operative imaging. Over 85% of lung and pleural malignancies express folate receptor alpha (FRA). It is important to note that FRA is expressed only in the proximal tubules of the kidneys, activated macrophages, and in the choroidal plexus. Thus, the false positive detection rate is expected to be extremely low. A group well known to us in the Netherlands has completed a pilot study utilizing a folate-fluorescein isothiocyanate (folate-FITC) conjugate in 12 patients with ovarian cancer. Another group of investigators in Mayo have subsequently performed this study on 20 more patients without any serious adverse events (personal communication). They report excellent sensitivity and specificity with this technique with only grade 1 side effects (allergic reaction). All side effects reversed when the injection was halted. Patients with a history of allergic reactions to insect bites should not participate (fluorescein is derived from the firefly insect, folate is an essential vitamin).

Condition or disease Intervention/treatment Phase
Lung and Pleural Malignancies Neoplasms Nodules Adenocarcinoma Drug: EC17 imaging contrast agent Phase 1

Detailed Description:
This will identify the margins and the lymph nodes that may have cancer cells during cancer surgery

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Intraoperative Imaging of Pulmonary Adenocarcinoma
Study Start Date : April 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IV Injection of EC17
The group will receive a single dose of EC17, infused over 10 minutes, prior to surgery. Then, during surgery, the EC-17 will be imaged with a camera that the investigators have developed.
Drug: EC17 imaging contrast agent
This is an imaging agent to locate lung adenocarcinoma cancer cells during surgery

Primary Outcome Measures :
  1. Number of FRA tumors identified by EC17 during surgery. [ Time Frame: Within two to four hours of injection of the EC17 ]
    Measure the number of patients who have a positive margin during lung cancer surgery 2 - 4 hours after receiving administration of EC17.

Secondary Outcome Measures :
  1. The number of participants that will have an adverse reaction to the EC17 [ Time Frame: Day 1 - Day 30 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients over 18 years of age
  • Patients presenting with a lung or pleural nodule or mass presumed to be resectable on pre-operative assessment
  • Good operative candidate
  • Subject capable of giving informed consent and participating in the process of consent

Exclusion Criteria:

  • Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
  • Patients with a history of anaphylactic reactions to Folate-FITC or insects
  • At-risk patient populations:

    • Homeless patients
    • Patients with drug or alcohol dependence
    • Children and neonates
    • Patients unable to participate in the consent process

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01778920

United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
VA Office of Research and Development
Principal Investigator: Sunil Singhal, MD Philadelphia VA Medical Center, Philadelphia, PA

Publications of Results:
Responsible Party: University of Pennsylvania Identifier: NCT01778920     History of Changes
Other Study ID Numbers: 815058
EC17 Lung Cancer ( Other Identifier: University of Pennsylvania )
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type