Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify TDLN in Early-stage NSCLC

Not Applicable

Completed

• Conditions: Early-stage Lung Cancer
• Interventions: Radiation: 99mTc-nanocolloid; Drug: ICG

• Registration Number: NCT05555199
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The patient wil receive intra- or peritumoral injections of 99mTc-nanocolloid if malignancy is found during a navigation bronchoscopy. A SPECT/CT-scan will be made to image injections sites and sentinel lymph nodes (SLN). If surgery takes place to treat the lung cancer, ICG will be injected and fluorescent lymph nodes will be extensively assessed by a pathologist.

Detailed Description

When malignancy is found during navigation bronchoscopy, study participants will receive intra- or peritumoral injections of 99mTc-nanocolloid. Following, up to 2 SPECT/CT-scans will be made to assess drainage of the injected tracer to the lymph nodes.

If patients undergo resection of the lung lesion, ICG will be injected. The involved lung tissue will be removed, followed by routine complete lymph node dissection. The fluorescent lymph nodes will be more extensively evaluated by the pathologist.

Study Timeline

• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-26
• Study Start: 2022-10-03
• Status Verified: 2024-04
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• ASA physical status 1-3;
• Lung lesion between 1 and 5 cm;
• Imaging-based disease free lymph nodes (N0);
• Patient is deemed a candidate for definitive lung tissue resection by a thoracic surgeon.

Exclusion Criteria

• Pregnancy;
• Inability to consent;
• Known or suspected allergy to 99mTc-nanocolloid or ICG.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	99mTc-nanocolloid	One interventional arm that will undergo all interventional procedures (when applicable).
Intervention	ICG	One interventional arm that will undergo all interventional procedures (when applicable).

Primary Outcome Measures

Name	Time	Method
Feasibility of SLN procedure	During the study intervention	This is a qualitative outcome measurement that will be assessed by the involved physicians based on the ability to inject 99mTc-nanocolloid and ICG, and the ability to detect the tumor draining lymph nodes based on their drainage patterns.

Secondary Outcome Measures

Name	Time	Method
Number of SLN found by SPECT/CT-imaging	On the day of the first intervention
Successfulness of injection method (intra- or peritumoral)	During the first intervention
Number of SLN found by ICG	On the day of the second intervention
Number of metastasis found by additional pathology	Up to two weeks after the second intervention

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands