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

Radboud University Medical Center

Status

Enrolling

Conditions

Early-stage Lung Cancer

Treatments

Drug: ICG

Radiation: 99mTc-nanocolloid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05555199

113036

NL81008.000.22 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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