Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules
1 other identifier
interventional
352
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 18, 2018
CompletedFirst Submitted
Initial submission to the registry
November 10, 2019
CompletedFirst Posted
Study publicly available on registry
November 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedNovember 18, 2019
November 1, 2019
2.5 years
November 10, 2019
November 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
within 1 week after surgery
Study Arms (4)
5mg/kg of ICG, 24h before surgery
ACTIVE COMPARATOR5mg/kg of indocyanine green, intravenously injection 24 hours before surgery
1mg/kg of ICG, 24h before surgery
EXPERIMENTAL1mg/kg of indocyanine green, intravenously injection 24 hours before surgery
5mg/kg of ICG, 48h before surgery
EXPERIMENTAL5mg/kg of indocyanine green, intravenously injection 48 hours before surgery
1mg/kg of ICG, 48h before surgery
EXPERIMENTAL1mg/kg of indocyanine green, intravenously injection 48 hours before surgery
Interventions
preoperatively infuse indocyanine green through peripheral vein
Eligibility Criteria
You may qualify if:
- Peripheral pulmonary solid nodules, with diameter 1-3 cm.
- Suitable for surgery and signed informed consent.
You may not qualify if:
- Liver dysfunction.
- Allergic to indocyanine green.
- Can't tolerate thoracoscopic surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wang Jun, MD
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief，Thoracic Surgery Service
Study Record Dates
First Submitted
November 10, 2019
First Posted
November 18, 2019
Study Start
December 18, 2018
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
November 18, 2019
Record last verified: 2019-11