- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01778920
Pilot and Feasibility Study of the Imaging Potential of EC17: Intraoperative Folate-fluorescein Conjugate (EC17) Lung Cancer (CA)
Intraoperative Imaging of Pulmonary Adenocarcinoma
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).
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Philadelphia VA Medical Center, Philadelphia, PA
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
This is an imaging agent to locate lung adenocarcinoma cancer cells during surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Within two to four hours of injection of the EC17
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of participants that will have an adverse reaction to the EC17
Time Frame: Day 1 - Day 30
|
Day 1 - Day 30
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sunil Singhal, MD, Philadelphia VA Medical Center, Philadelphia, PA
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 815058
- EC17 Lung Cancer (Other Identifier: University of Pennsylvania)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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