Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules

November 13, 2019 updated by: Jun Wang, Peking University People's Hospital
Fluorescence-navigated thoracoscopic imaging with indocyanine green (ICG) is a novel technique for detection of small pulmonary nodules other than traditional radiography or intraoperative palpation. As a non-targeted fluorescent contrast agent, ICG accumulates in tumors by the enhanced permeability and retention effect (EPR), making the lesions fluoresce under fluorescent imaging. However, the optimal dosage and injection time of ICG are still under exploration. Hence, we perform this study in humans made up of four groups to determine the optimal time and dose.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

352

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Peripheral pulmonary solid nodules, with diameter 1-3 cm.
  • Suitable for surgery and signed informed consent.

Exclusion Criteria:

  • Liver dysfunction.
  • Allergic to indocyanine green.
  • Can't tolerate thoracoscopic surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 5mg/kg of ICG, 24h before surgery
5mg/kg of indocyanine green, intravenously injection 24 hours before surgery
Procedure: Preoperative Infusion of Indocyanine Green
preoperatively infuse indocyanine green through peripheral vein
EXPERIMENTAL: 1mg/kg of ICG, 24h before surgery
1mg/kg of indocyanine green, intravenously injection 24 hours before surgery
Procedure: Preoperative Infusion of Indocyanine Green
preoperatively infuse indocyanine green through peripheral vein
EXPERIMENTAL: 5mg/kg of ICG, 48h before surgery
5mg/kg of indocyanine green, intravenously injection 48 hours before surgery
Procedure: Preoperative Infusion of Indocyanine Green
preoperatively infuse indocyanine green through peripheral vein
EXPERIMENTAL: 1mg/kg of ICG, 48h before surgery
1mg/kg of indocyanine green, intravenously injection 48 hours before surgery
Procedure: Preoperative Infusion of Indocyanine Green
preoperatively infuse indocyanine green through peripheral vein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal-to-background Ratio (SBR) of the Tumor and Normal Parenchyma
Time Frame: within 1 week after surgery
We use image analysis software ImageJ to evaluate the strength of luminosity in tumors and normal parenchyma using intraoperative images and calculate signal-to-background-ratios.
within 1 week after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Study Director: Wang Jun, MD, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 18, 2018

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

November 10, 2019

First Submitted That Met QC Criteria

November 13, 2019

First Posted (ACTUAL)

November 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018PHB144-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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