Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules

NCT ID: NCT04165603

Last Updated: 2019-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Nodule, Solitary Pulmonary Nodule, Multiple

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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5mg/kg of ICG, 24h before surgery

5mg/kg of indocyanine green, intravenously injection 24 hours before surgery

Group Type ACTIVE_COMPARATOR

Preoperative Infusion of Indocyanine Green

Intervention Type PROCEDURE

preoperatively infuse indocyanine green through peripheral vein

1mg/kg of ICG, 24h before surgery

1mg/kg of indocyanine green, intravenously injection 24 hours before surgery

Group Type EXPERIMENTAL

Preoperative Infusion of Indocyanine Green

Intervention Type PROCEDURE

preoperatively infuse indocyanine green through peripheral vein

5mg/kg of ICG, 48h before surgery

5mg/kg of indocyanine green, intravenously injection 48 hours before surgery

Group Type EXPERIMENTAL

Preoperative Infusion of Indocyanine Green

Intervention Type PROCEDURE

preoperatively infuse indocyanine green through peripheral vein

1mg/kg of ICG, 48h before surgery

1mg/kg of indocyanine green, intravenously injection 48 hours before surgery

Group Type EXPERIMENTAL

Preoperative Infusion of Indocyanine Green

Intervention Type PROCEDURE

preoperatively infuse indocyanine green through peripheral vein

Interventions

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Preoperative Infusion of Indocyanine Green

preoperatively infuse indocyanine green through peripheral vein

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jun Wang

Chief,Thoracic Surgery Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wang Jun, MD

Role: STUDY_DIRECTOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Feng Yang, MD

Role: CONTACT

(+86) 18612978269

Tiezheng Li, MD

Role: CONTACT

(+86) 18811768786

Facility Contacts

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Feng Yang, MD

Role: primary

+8618612978269

Other Identifiers

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2018PHB144-01

Identifier Type: -

Identifier Source: org_study_id

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