Minimally Invasive Imagery With Indocyanine Green

NCT02621268 | Completed Phase 1 DMC

• 1 other identifier: 820766
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Determine if ICG administered pre-operatively, then imaged intraoperatively using our cameras, will aid in the identification of a suspected thoracic nodules, margins, lymph nodes and satellite nodules during minimally invasive procedures. The investigators intend on enrolling 48 Subjects in this study. The study is focusing on patients presenting with suspected thoracic cancers who are considered to be good minimally invasive surgical candidates

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Ability of imaging system to detect expression of ICG in nodule/mass (i.e. tumor) and discern uptake of dye by tumor

  Detected with imaging probe during minimally invasive procedure

  36 months

Secondary Outcomes (1)

• Incidence rates of all adverse events, treatment-emergent adverse events, and adverse device events from time of ICG administration through participants' first, post-operative appointment with surgeon

  36 Months

Study Arms (1)

Indocyanine Green

EXPERIMENTAL

Dosage calculated by weight of individual, 5mg/kg.

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

Infusion of ICG 24 hours prior to surgery

Also known as: ICG

Indocyanine Green

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over 18 years of age
• Patients presenting with a thoracic nodule presumed to be resectable cancer on pre-operative assessment
• Good minimally invasive operative candidates 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 human chorionic gonadotropin (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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Mountain CF, Dresler CM. Regional lymph node classification for lung cancer staging. Chest. 1997 Jun;111(6):1718-23. doi: 10.1378/chest.111.6.1718.

  PMID: 9187199 BACKGROUND

• Kimura T, Muguruma N, Ito S, Okamura S, Imoto Y, Miyamoto H, Kaji M, Kudo E. Infrared fluorescence endoscopy for the diagnosis of superficial gastric tumors. Gastrointest Endosc. 2007 Jul;66(1):37-43. doi: 10.1016/j.gie.2007.01.009.

  PMID: 17591472 BACKGROUND

• Gotoh M, Yamamoto Y, Igai H, Chang S, Huang C, Yokomise H. Clinical application of infrared thoracoscopy to detect bullous or emphysematous lesions of the lung. J Thorac Cardiovasc Surg. 2007 Dec;134(6):1498-501. doi: 10.1016/j.jtcvs.2007.07.051.

  PMID: 18023672 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sunil Singhal, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Thoracic Surgery Research Laboratory

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 3, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

US (1)