Minimally Invasive Imagery With Indocyanine Green

NCT ID: NCT02621268

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-11-30

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

Detailed Description

According to the World Health Organization, lung cancer is the most common cause of cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide annually as of 2004.

Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismal 53% for Stage I and 32% for Stage II (1). The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery it would be possible for us to improve the rates of recurrence free patients and thus overall survival.

The use of an ICG probe will allow for the operating field and lung tissue to be observed in real-time.

ICG has been used in the clinical settings since 1957. There is a wealth of data available attesting to the safety of this drug injected at its current clinically indicated dosing level. ICG has been shown to preferentially uptake in esophageal tumors as opposed to surrounding epithelial lumen after one minute of IV exposure (2). Additionally, the same group reported being able to better characterize the vascularization of the tumor to further clarify the invasiveness of the cancer. ICG usage has been shown to be safe in a similar clinical setting by the Gotoh group, who used ICG to detect and characterize bullous and emphysematous lesion of the lung in video assisted thoracoscopic surgeries (VATS) with Infrared Thoracoscopy that were not previously detectable by white light (3).

The currently proposed trial is a single center, open-label pilot/observational cohort study. Patients with a diagnosis of resectable thoracic nodule/mass who are presumed to be resectable via minimally invasive surgery as determined by pre-operative assessment at the Hospital of the University of Pennsylvania will be included.

Conditions

Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Indocyanine Green

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

Group Type: EXPERIMENTAL

Indocyanine Green

Intervention Type: DRUG

Infusion of ICG 24 hours prior to surgery

Interventions

Indocyanine Green

Infusion of ICG 24 hours prior to surgery

Intervention Type: DRUG

Other Intervention Names

ICG

Eligibility Criteria

Inclusion Criteria

1. Adult patients over 18 years of age

2. Patients presenting with a thoracic nodule presumed to be resectable cancer on pre-operative assessment

3. Good minimally invasive operative candidates as determined by a thoracic oncology multidisciplinary team

4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria

1. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery

2. Subjects with a history of iodide allergies

3. At-risk patient populations

1. Homeless patients

2. Patients with drug or alcohol dependence

3. Children and neonates

4. Patients unable to participate in the consent process

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Sunil Singhall

Director, Thoracic Surgery Research Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sunil Singhal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 9187199 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17591472 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18023672 (View on PubMed)

Other Identifiers

820766

Identifier Type: -

Identifier Source: org_study_id