Intraoperative Imaging of Pulmonary Adenocarcinoma

Lung Cancer Clinical Trial

Official title:

Intraoperative Imaging of Pulmonary Adenocarcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02653612
• Other study ID #: CLNB-009-14F
• Status: Withdrawn
• Phase: Phase 1
• First received: January 8, 2016
• Last updated: February 28, 2018
• Start date: January 1, 2016
• Est. completion date: February 26, 2018

Study information

• Verified date: February 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 26, 2018
• Est. primary completion date: February 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• lung cancer

• surgical candidate

• operable

• resectable

Exclusion Criteria:

• no allergies to contrast dyes

Related Conditions & MeSH terms

• Adenocarcinoma
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• EC17 imaging contrast agent
This is an imaging agent to locate lung adenocarcinoma cancer cells during surgery

Locations

Country	Name	City	State
United States	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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