Back to resultsFluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules
Primary Purpose
Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Preoperative Infusion of Indocyanine Green
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Nodule, Solitary
Eligibility Criteria
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.
Sites / Locations
- Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
5mg/kg of ICG, 24h before surgery
1mg/kg of ICG, 24h before surgery
5mg/kg of ICG, 48h before surgery
1mg/kg of ICG, 48h before surgery
Arm Description
5mg/kg of indocyanine green, intravenously injection 24 hours before surgery
1mg/kg of indocyanine green, intravenously injection 24 hours before surgery
5mg/kg of indocyanine green, intravenously injection 48 hours before surgery
1mg/kg of indocyanine green, intravenously injection 48 hours before surgery
Outcomes
Primary Outcome Measures
Signal-to-background Ratio (SBR) of the Tumor and Normal Parenchyma
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04165603
First Posted
November 10, 2019
Last Updated
November 13, 2019
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04165603
Brief Title
Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules
Official Title
Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
352 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
5mg/kg of ICG, 24h before surgery
Arm Type
Active Comparator
Arm Description
5mg/kg of indocyanine green, intravenously injection 24 hours before surgery
Arm Title
1mg/kg of ICG, 24h before surgery
Arm Type
Experimental
Arm Description
1mg/kg of indocyanine green, intravenously injection 24 hours before surgery
Arm Title
5mg/kg of ICG, 48h before surgery
Arm Type
Experimental
Arm Description
5mg/kg of indocyanine green, intravenously injection 48 hours before surgery
Arm Title
1mg/kg of ICG, 48h before surgery
Arm Type
Experimental
Arm Description
1mg/kg of indocyanine green, intravenously injection 48 hours before surgery
Intervention Type
Procedure
Intervention Name(s)
Preoperative Infusion of Indocyanine Green
Intervention Description
preoperatively infuse indocyanine green through peripheral vein
Primary Outcome Measure Information:
Title
Signal-to-background Ratio (SBR) of the Tumor and Normal Parenchyma
Description
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.
Time Frame
within 1 week after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Yang, MD
Phone
(+86) 18612978269
Email
yangfeng1007@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tiezheng Li, MD
Phone
(+86) 18811768786
Email
tiezhengli@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Jun, MD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Yang, MD
Phone
+8618612978269
Email
yangfeng1007@sina.com
12. IPD Sharing Statement
Learn more about this trial
Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules
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