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

This study has been completed.
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01778920
First received: January 18, 2013
Last updated: May 16, 2016
Last verified: December 2015
  Purpose

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 Intervention Phase
Lung and Pleural Malignancies
Neoplasms
Nodules
Adenocarcinoma
Drug: EC17 imaging contrast agent
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Intraoperative Imaging of Pulmonary Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Number of FRA tumors identified by EC17 during surgery. [ Time Frame: Within two to four hours of injection of the EC17 ] [ Designated as safety issue: No ]
    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:
  • The number of participants that will have an adverse reaction to the EC17 [ Time Frame: Day 1 - Day 30 ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: April 2012
Study Completion Date: May 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778920

Locations
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
Investigators
Principal Investigator: Sunil Singhal, MD Philadelphia VA Medical Center, Philadelphia, PA
  More Information

Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01778920     History of Changes
Other Study ID Numbers: 815058  EC17 Lung Cancer 
Study First Received: January 18, 2013
Last Updated: May 16, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 21, 2016