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Completed

NCT Number: NCT05555199

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

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.

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Key information

Conditions

Early-Stage Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

99mTc-nanocolloid

Radiation

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

Other names: Elective navigation bronchoscopy, SLN procedure

ICG

Drug

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

Other names: Elective lung surgery, SLN procedure

Primary outcomes

  1. Feasibility of SLN procedure

    Time frame: 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 outcomes

  1. Successfulness of injection method (intra- or peritumoral)

    Time frame: During the first intervention

  2. Number of SLN found by SPECT/CT-imaging

    Time frame: On the day of the first intervention

  3. Number of SLN found by ICG

    Time frame: On the day of the second intervention

  4. Number of metastasis found by additional pathology

    Time frame: Up to two weeks after the second intervention

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Johnson & Johnson
  • Philips Healthcare

Registry information

Official study title

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

Acronym: INITIATE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2022
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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