early-stage lung cancer lung nodule lung tumor
Conditions
Interventions
When malignancy is found on rapid on-site evaluation (ROSE) during the
navigation bronchoscopy, study participants will receive around 4 intra- and/or
peritumoral injections (depending on tumor char
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Suspected (operable) lung tumor of 1 to 5 cm that is referred for diagnosis by a navigation bronchoscopy.
Exclusion criteria
Exclusion criteria: Allergic to 99mTc-nanocolloid or ICG.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to determine the feasibility of identifying and analyzing the TDLN in patients with NSCLC (cT1 to cT2b) on SPECT/CT-imaging and during surgical resection using a radioactive and fluorescent tracer. To verify the objective, injections (at multiple locations by repositioning of the catheter) should be feasible during a navigation bronchoscopy using 99mTc-nanocolloid and peri-surgically (through trans-thoracic needle or navigation bronchoscopy) using ICG and the drainage of these tracers should be visible on either SPECT/CT-imaging or a fluorescent camera. Feasibility of identification are qualitative and quantitative (how many nodes on imaging and surgery) endpoints that will be assessed by consensus between a pulmonary physician, technical physician, nuclear physician and a cardiothoracic surgeon that are part of the study team. | — |
Secondary
| Measure | Time frame |
|---|---|
| The quality of drainage after intra- or peritumoral injections, the Pioneer Plus catheter as endobronchial catheter for sampling, injection and use of the real-time ultrasound-imaging, the removal of SLN during surgery based on fluorescence, the added value of the additional pathological evaluation and the immunological reactions found in the SLN and tumor. | — |
Countries
Netherlands
Outcome results
None listed