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Intraoperative Imaging of Pulmonary Adenocarcinoma

Primary Purpose

Lung Cancer

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EC17 imaging contrast agent
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring surgery, folate receptor

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • lung cancer
  • surgical candidate
  • operable
  • resectable

Exclusion Criteria:

- no allergies to contrast dyes

Sites / Locations

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Arm

Arm Description

This cohort will receive the contrast agent

Outcomes

Primary Outcome Measures

Margin assessment
Percentage of surgeries which detect tumor cells at the surgical margin
Lymph node assessment
Number of residual tumor cells in the lymph nodes detected via intraoperative imaging of a FR-targeted fluorescent contrast agent

Secondary Outcome Measures

Full Information

First Posted
January 8, 2016
Last Updated
February 28, 2018
Sponsor
VA Office of Research and Development
Collaborators
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02653612
Brief Title
Intraoperative Imaging of Pulmonary Adenocarcinoma
Official Title
Intraoperative Imaging of Pulmonary Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
This study has been terminated, without having enrolled any participants
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
February 26, 2018 (Actual)
Study Completion Date
February 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
surgery, folate receptor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
This cohort will receive the contrast agent
Intervention Type
Drug
Intervention Name(s)
EC17 imaging contrast agent
Intervention Description
This is an imaging agent to locate lung adenocarcinoma cancer cells during surgery
Primary Outcome Measure Information:
Title
Margin assessment
Description
Percentage of surgeries which detect tumor cells at the surgical margin
Time Frame
At the time of surgery
Title
Lymph node assessment
Description
Number of residual tumor cells in the lymph nodes detected via intraoperative imaging of a FR-targeted fluorescent contrast agent
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: lung cancer surgical candidate operable resectable Exclusion Criteria: - no allergies to contrast dyes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Gaughan, MD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intraoperative Imaging of Pulmonary Adenocarcinoma

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