Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Intraoperative Folate-fluorescein Conjugate (EC17) Lung Cancer (CA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Sunil Singhall, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01778920
First received: January 18, 2013
Last updated: June 17, 2014
Last verified: November 2013

January 18, 2013
June 17, 2014
April 2012
April 2015   (final data collection date for primary outcome measure)
The ability of EC17 and the imaging system to detect FRA positive tumors during surgery conducted 2-4 hours post EC-17 administration. [ Time Frame: Within two to four hours of injection of the EC17 ] [ Designated as safety issue: No ]
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 [ Time Frame: Within two hours of injection of the EC17 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01778920 on ClinicalTrials.gov Archive Site
The number of participants that will have an adverse reaction to the EC17 [ Time Frame: Day 1 - Day 30 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intraoperative Folate-fluorescein Conjugate (EC17) Lung Cancer (CA)
Pilot and Feasibility Study of the Imaging Potential of EC17

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-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).

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Lung and Pleural Malignancies
  • Neoplasms
  • Nodules
Drug: EC17
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.
Intervention: Drug: EC17
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
Not Provided
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Sunil Singhal, M.D. sunil.singhal@uphs.upenn.edu
United States
 
NCT01778920
EC17 Lung Cancer, 815058
Yes
Sunil Singhall, University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Sunil Singhal, M.D. University of Pennsylvania
University of Pennsylvania
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP