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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

EC17 imaging contrast agent

Sunil Singhal, MD

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).

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

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

Intraoperative Imaging of Pulmonary Adenocarcinoma

Measure the number of patients who have a positive margin during lung cancer surgery 2 - 4 hours after receiving administration of EC17.

VA Office of Research and Development

University of Pennsylvania

Respiratory Tract Neoplasms

Thoracic Neoplasms

This cohort will receive the contrast agent

Colleen Gaughan, MD

The goal is to improve surgery by preventing tumor cells from being left behind at the time of surgery. This includes finding residual tumor cells in the wound after surgery.

The goal is to improve the intraoperative identification of tumor cells at positive margins and regional metastases that may be missed by a surgeon during a pulmonary resection. Improved identification of tumor cells will result in superior disease clearance and more accurate clinical staging. The investigators hypothesize that targeted fluorescent imaging during surgery will improve identification of positive margins and metastases. Since folate receptor alpha (FR ) is expressed on 55% of resectable lung cancer, the investigators will utilize a fluorescent probe that targets these tumors. As real-time imaging provides more information to the surgeon, more personalized and directed operations can be conducted. This work will allow for more preservation of normal tissue, decreased morbidity, decreased surgical time, increased surgical confidence, improved cancer detection, decreased unnecessary surgery and ultimately improved tumor free survival. This technology should transform clinical surgery from an art that depends fully on the human factor to a procedure that has precision and fail safes.

Percentage of surgeries which detect tumor cells at the surgical margin

Number of residual tumor cells in the lymph nodes detected via intraoperative imaging of a FR-targeted fluorescent contrast agent

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot and Feasibility Study of the Imaging Potential of EC17: Intraoperative Folate-fluorescein Conjugate (EC17) Lung Cancer (CA)	NCT01778920	Lung and Pleura... Neoplasms Nodules Adenocarcinoma	EC17 imaging co...	18 Years -	University of Pennsylvania
Intraoperative Imaging of Pulmonary Adenocarcinoma	NCT02653612	Lung Cancer	EC17 imaging co...	18 Years - 99 Years	VA Office of Research and Development

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