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

Phase 1

Completed

• Conditions: Nodules; Lung and Pleural Malignancies; Neoplasms; Adenocarcinoma
• Interventions: Drug: EC17 imaging contrast agent

• Registration Number: NCT01778920
• Lead Sponsor: 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).

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-01-18
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-29
• Status Verified: 2015-12
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IV Injection of EC17	EC17 imaging contrast agent	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.

Primary Outcome Measures

Name	Time	Method
Number of FRA tumors identified by EC17 during surgery.	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

Name	Time	Method
The number of participants that will have an adverse reaction to the EC17	Day 1 - Day 30

Trial Locations

Locations (2)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Philadelphia VA Medical Center, Philadelphia, PA; 🇺🇸 Philadelphia, Pennsylvania, United States