Intraoperative Imaging of Pulmonary Adenocarcinoma

Phase 1

Withdrawn

• Conditions: Lung Cancer
• Interventions: Drug: EC17 imaging contrast agent

• Registration Number: NCT02653612
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-12
• Status Verified: 2018-02
• Primary Completion: 2018-02-26
• Study Completion: 2018-02-26
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• lung cancer
• surgical candidate
• operable
• resectable

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Exclusion Criteria

• no allergies to contrast dyes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Arm	EC17 imaging contrast agent	This cohort will receive the contrast agent

Primary Outcome Measures

Name	Time	Method
Margin assessment	At the time of surgery	Percentage of surgeries which detect tumor cells at the surgical margin
Lymph node assessment	4 hours	Number of residual tumor cells in the lymph nodes detected via intraoperative imaging of a FR-targeted fluorescent contrast agent

Trial Locations

Locations (1)

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA; 🇺🇸 Philadelphia, Pennsylvania, United States