Early-stage Lung Cancer
Conditions
Keywords
Sentinel Lymph Node procedure, 99mTc-nanocolloid, ICG, SPECT/CT-imaging
Brief summary
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.
Detailed 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.
Interventions
RADIATION99mTc-nanocolloid
Injection of 99mTc-nanocolloid when lung cancer is diagnosed during a navigation bronchoscopy, followed by one or two SPECT/CT-scans.
DRUGICG
If patient undergoes surgery to treat the lung cancer, ICG will be injected and retrieved fluorescent lymph nodes will undergo additional pathological assessment.
Sponsors
Philips Healthcare
Johnson & Johnson
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a prospective, single-center, non-randomized, interventional study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of SLN procedure | 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
| Measure | Time frame |
|---|---|
| Successfulness of injection method (intra- or peritumoral) | During the first intervention |
| Number of SLN found by SPECT/CT-imaging | On the day of the first intervention |
| Number of SLN found by ICG | On the day of the second intervention |
| Number of metastasis found by additional pathology | Up to two weeks after the second intervention |
Countries
Netherlands
Outcome results
None listed