Injection of 99mTc-nanocolloid and ICG to identify, retrieve and qualify tumor draining lymph nodes in early-stage lungcancer
Recruiting
- Conditions
- 1003866610029107lung tumorearly-stage lung cancerlung nodule
- Registration Number
- NL-OMON51465
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Suspected (operable) lung tumor of 1 to 5 cm that is referred for diagnosis by
a navigation bronchoscopy.
Exclusion Criteria
Allergic to 99mTc-nanocolloid or ICG.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to determine the feasibility of identifying and<br /><br>analyzing the TDLN in patients with NSCLC (cT1 to cT2b) on SPECT/CT-imaging and<br /><br>during surgical resection using a radioactive and fluorescent tracer. To verify<br /><br>the objective, injections (at multiple locations by repositioning of the<br /><br>catheter) should be feasible during a navigation bronchoscopy using<br /><br>99mTc-nanocolloid and peri-surgically (through trans-thoracic needle or<br /><br>navigation bronchoscopy) using ICG and the drainage of these tracers should be<br /><br>visible on either SPECT/CT-imaging or a fluorescent camera. Feasibility of<br /><br>identification are qualitative and quantitative (how many nodes on imaging and<br /><br>surgery) endpoints that will be assessed by consensus between a pulmonary<br /><br>physician, technical physician, nuclear physician and a cardiothoracic surgeon<br /><br>that are part of the study team.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The quality of drainage after intra- or peritumoral injections, the Pioneer<br /><br>Plus catheter as endobronchial catheter for sampling, injection and use of the<br /><br>real-time ultrasound-imaging, the removal of SLN during surgery based on<br /><br>fluorescence, the added value of the additional pathological evaluation and the<br /><br>immunological reactions found in the SLN and tumor.</p><br>