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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2024-10-31

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.

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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.

Conditions

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Early-stage Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a prospective, single-center, non-randomized, interventional study.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention

One interventional arm that will undergo all interventional procedures (when applicable).

Group Type EXPERIMENTAL

99mTc-nanocolloid

Intervention Type RADIATION

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

ICG

Intervention Type DRUG

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

Interventions

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99mTc-nanocolloid

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

Intervention Type RADIATION

ICG

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

Intervention Type DRUG

Other Intervention Names

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Elective navigation bronchoscopy SLN procedure Elective lung surgery SLN procedure

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.