NCT02653612

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2018

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

2.2 years

First QC Date

January 8, 2016

Last Update Submit

February 28, 2018

Conditions

Lung Cancer

Keywords

surgeryfolate receptor

Outcome Measures

Primary Outcomes (2)

  • Margin assessment

    Percentage of surgeries which detect tumor cells at the surgical margin

    At the time of surgery

  • 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

Study Arms (1)

Experimental Arm

EXPERIMENTAL

This cohort will receive the contrast agent

Drug: EC17 imaging contrast agent

Interventions

EC17 imaging contrast agentDRUG

This is an imaging agent to locate lung adenocarcinoma cancer cells during surgery

Experimental Arm

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lung cancer
  • surgical candidate
  • operable
  • resectable

You may not qualify if:

  • \- no allergies to contrast dyes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Colleen Gaughan, MD

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 12, 2016

Study Start

January 1, 2016

Primary Completion

February 26, 2018

Study Completion

February 26, 2018

Last Updated

March 2, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)