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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify Tumor Draining Lymph Nodes in Early-stage Lung Cancer

Conditions
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Early-stage Lung Cancer

Intervention / Treatment
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* Radiation: 99mTc-nanocolloid
* Drug: ICG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, single-center, non-randomized, interventional study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>One interventional arm that will undergo all interventional procedures (when applicable). | Radiation: 99mTc-nanocolloid<br>* Injection of 99mTc-nanocolloid when lung cancer is diagnosed during a navigation bronchoscopy, followed by one or two SPECT/CT-scans.<br>* Other names: SLN procedure;Drug: ICG<br>* If patient undergoes surgery to treat the lung cancer, ICG will be injected and retrieved fluorescent lymph nodes will undergo additional pathological assessment.<br>* Other names: SLN procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of SLN procedure | 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. | During the study intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successfulness of injection method (intra- or peritumoral) |  | During the first intervention | 
| Number of SLN found by SPECT/CT-imaging |  | On the day of 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICG, Sentinel Lymph Node procedure, 99mTc-nanocolloid, SPECT/CT-imaging