NCT01335893

Brief Summary

Our specific aim is to determine if Indocyanine Green (ICG) administered intraoperatively and imaged using our camera will aid in the identification of a suspected lung nodule.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 1, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2014

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

3.6 years

First QC Date

April 1, 2011

Last Update Submit

February 1, 2018

Conditions

Lung Neoplasms

Keywords

ImagingIndocyanine GreenLung CancerLung NeoplasmsPreliminary Study

Outcome Measures

Primary Outcomes (1)

  • Imaging effectiveness of ICG and imaging system.

    The primary end-point of the study is to determine the sensitivity of ICG uptake and expression in identifying lung nodules / masses when excited by an imaging probe intraoperatively. This will be accomplished by using the probe to image the tumor, then subtracting the background from surrounding thoracic structures. Uptake will be measured using the scale of the instrument, an arbitrary value of between 1 and 10,000. Uptake will be summarized using the mean and 95% confidence interval (CI).

    1 day after injection of ICG

Study Arms (1)

ICG injection group

EXPERIMENTAL

This group will receive a single dose of ICG, diluted in saline solution, prior to surgery. Then, during their surgery, they will be imaged with the camera and imaging probe we have developed.

Drug: Indocyanine Green

Interventions

Indocyanine GreenDRUG

Dose will be diluted in saline solution. This will be a single dose given before the surgery intravenously.

Also known as: ICG, Indocyanine Green USP, for injection
ICG injection group

Eligibility Criteria

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

You may qualify if:

  • Adult patients over 18 years of age
  • Patients presenting with a lung nodule or mass presumed to be resectable stage I, II, or IIIa non-small call lung cancer on pre-operative assessment
  • Good operative candidate as determined by a thoracic oncology multidisciplinary team
  • Subject capable of giving informed consent and participating in the process of consent

You may not qualify if:

  • Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
  • Subjects with a history of iodide allergies
  • At-risk patient populations
  • Homeless patients
  • Patients with drug or alcohol dependence
  • Children and neonates
  • Patients unable to participate in the consent process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Okusanya OT, Holt D, Heitjan D, Deshpande C, Venegas O, Jiang J, Judy R, DeJesus E, Madajewski B, Oh K, Wang M, Albelda SM, Nie S, Singhal S. Intraoperative near-infrared imaging can identify pulmonary nodules. Ann Thorac Surg. 2014 Oct;98(4):1223-30. doi: 10.1016/j.athoracsur.2014.05.026. Epub 2014 Aug 5.

    PMID: 25106680RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Indocyanine GreenWW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsShort Chain Dehydrogenase-ReductasesNAD (+) and NADP (+) Dependent Alcohol OxidoreductasesAlcohol OxidoreductasesOxidoreductasesEnzymesEnzymes and CoenzymesTumor Suppressor ProteinsNeoplasm ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Sunil Singhal, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 14, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 14, 2014

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

US(1)