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

Radboud University Medical Center72 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Early-stage Lung Cancer

Interventions

99mTc-nanocolloidRADIATION

Injection of 99mTc-nanocolloid when lung cancer is diagnosed during a navigation bronchoscopy, followed by one or two SPECT/CT-scans.

ICGDRUG

If patient undergoes surgery to treat the lung cancer, ICG will be injected and retrieved fluorescent lymph nodes will undergo additional pathological assessment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Radboudumc

Nijmegen, Gelderland, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: During the study intervention

Secondary Outcomes

Successfulness of injection method (intra- or peritumoral)

Time frame: During the first intervention

Number of SLN found by SPECT/CT-imaging

Time frame: On the day of the first intervention

Number of SLN found by ICG

Time frame: On the day of the second intervention

Number of metastasis found by additional pathology

Time frame: Up to two weeks after the second intervention

Data from ClinicalTrials.gov

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