Near-Infrared Perfusion During Minimally Invasive Thoracic Surgery Download

NCT05346380 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2020P000835
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective, (NSR), single-center feasibility study of the Olympus VE2 NIR Imaging System to assess perfusion using NIR during minimally invasive esophagectomy and pulmonary segmentectomy. The aims of the study are: 1\. To utilize NIR intraoperative imaging with the Olympus VE2 NIR Imaging System to: i. Characterize gastric conduit perfusion during esophagectomy and, ii. Identify segmental anatomy during sublobar pulmonary resection (segmentectomy) after intraoperative, intravenous delivery of low-dose 0.15 mg/kg of ICG.

Conditions

Lung Neoplasms; Esophageal Lesion

Outcome Measures

Primary Outcomes (2)

• To utilize NIR intraoperative imaging with the Olympus VE2 NIR Imaging System for esophagectomy patients.

  Fluorescent intensity, visualization of the intersegmental plane with NIR imaging, image quality will all be ranked by the surgeon as "below standard, average, or good" compared to the standard of care as they identify segmental anatomy during sublobar pulmonary resection (segmentectomy) after intraoperative, intravenous delivery of low-dose 0.15 mg/kg of ICG.

  During surgery

• To utilize NIR intraoperative imaging with the Olympus VE2 NIR Imaging System for segmentectomy patients.

  Fluorescent intensity, visualization of the intersegmental plane with NIR imaging, image quality will all be ranked by the surgeon as "below standard, average, or good" compared to the standard of care as they identify esophageal anatomy during esophagectomy after intraoperative, intravenous delivery of low-dose 0.15 mg/kg of ICG.

  During surgery

Study Arms (2)

During Minimally Invasive Pulmonary Segmentectomy (Group 2)

EXPERIMENTAL

Device: Olympus VE2 NIR Imaging System; Drug: Indocyanine green

During Minimally Invasive Esophagectomy (Group 1)

EXPERIMENTAL

Device: Olympus VE2 NIR Imaging System; Drug: Indocyanine green

Interventions

Olympus VE2 NIR Imaging System DEVICE

A prospective, (NSR), single-center feasibility study of the Olympus VE2 NIR Imaging System to assess perfusion using NIR during minimally invasive esophagectomy or pulmonary segmentectomy based on treatment arm.

During Minimally Invasive Esophagectomy (Group 1); During Minimally Invasive Pulmonary Segmentectomy (Group 2)

Indocyanine green DRUG

intravenous delivery of low-dose 0.15 mg/kg of ICG combined with Olympus VE2 NIR Imaging System to assess perfusion using NIR during minimally invasive esophagectomy or pulmonary segmentectomy based on treatment arm

During Minimally Invasive Esophagectomy (Group 1); During Minimally Invasive Pulmonary Segmentectomy (Group 2)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a suspicious lung lesion for which a minimally invasive segmentectomy is planned -OR- sub-ject has an esophageal lesion for which an esophagectomy is planned -
• Subject is 18 years of age or older
• Subject is willing and able to provide informed consent

You may not qualify if:

• Subject is not eligible for surgical resection as determined by the treating physician
• Subject has known or suspected allergy to Iodine, shellfish or intravenous contrast
• Subject is not eligible or considered high risk for surgical resection as determined by pre-operative spirometry
• Subject is female and of childbearing age who is currently pregnant or who is planning to become pregnant within the study
• Subject is unable and unwilling to provide informed consent
• Subject has liver disease or is taking drugs impact liver metabolism.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Olympus: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• DeLong JC, Kelly KJ, Jacobsen GR, Sandler BJ, Horgan S, Bouvet M. The benefits and limitations of robotic assisted transhiatal esophagectomy for esophageal cancer. J Vis Surg. 2016 Sep 8;2:156. doi: 10.21037/jovs.2016.09.01. eCollection 2016.

  PMID: 29078542 BACKGROUND

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8.

  PMID: 30620402 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Christopher Morse, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator MD

Model Details: The treatment arms are separated by type of surgery. Arm 1 is esophagectomy, Arm 2 is segmentectomy.

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: April 26, 2022
• Study Start: October 29, 2020
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)