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

R

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

  • Pregnancy;
  • Inability to consent;
  • Known or suspected allergy to 99mTc-nanocolloid or ICG.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Intervention
Experimental group
Description:
One interventional arm that will undergo all interventional procedures (when applicable).
Treatment:
Radiation: 99mTc-nanocolloid
Drug: ICG

Trial contacts and locations

1

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Central trial contact

Erik H van der Heijden, Dr.; Desi KM ter Woerds, MSc.

Data sourced from clinicaltrials.gov

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