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Clinical Trials/NCT02653612
NCT02653612WithdrawnPhase 1

Intraoperative Imaging of Pulmonary Adenocarcinoma

VA Office of Research and Development1 site in 1 countryStarted: January 1, 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Withdrawn
Locations
1
Primary Endpoint
Margin assessment

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • lung cancer
  • surgical candidate
  • resectable

Exclusion Criteria

  • no allergies to contrast dyes

Arms & Interventions

Experimental Arm

Experimental

This cohort will receive the contrast agent

Intervention: EC17 imaging contrast agent (Drug)

Outcomes

Primary Outcomes

Margin assessment

Time Frame: At the time of surgery

Percentage of surgeries which detect tumor cells at the surgical margin

Lymph node assessment

Time Frame: 4 hours

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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