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Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules

Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04165603
Enrollment
352
Registered
2019-11-18
Start date
2018-12-18
Completion date
2021-06-30
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Nodule, Multiple, Pulmonary Nodule, Solitary

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.

Interventions

PROCEDUREPreoperative Infusion of Indocyanine Green

preoperatively infuse indocyanine green through peripheral vein

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Signal-to-background Ratio (SBR) of the Tumor and Normal Parenchymawithin 1 week after surgeryWe 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.

Countries

China

Contacts

Primary ContactFeng Yang, MD
yangfeng1007@sina.com(+86) 18612978269
Backup ContactTiezheng Li, MD
tiezhengli@foxmail.com(+86) 18811768786

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026