INITIATE: Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify TDLN in Early-stage NSCLC
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Intervention One interventional arm that will undergo all interventional procedures (when applicable). |
Radiation: 99mTc-nanocolloid
Injection of 99mTc-nanocolloid when lung cancer is diagnosed during a navigation bronchoscopy, followed by one or two SPECT/CT-scans.
Other Names:
Drug: ICG
If patient undergoes surgery to treat the lung cancer, ICG will be injected and retrieved fluorescent lymph nodes will undergo additional pathological assessment.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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ASA physical status 1-3;
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Lung lesion between 1 and 5 cm;
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Imaging-based disease free lymph nodes (N0);
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Patient is deemed a candidate for definitive lung tissue resection by a thoracic surgeon.
Exclusion Criteria:
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Pregnancy;
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Inability to consent;
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Known or suspected allergy to 99mTc-nanocolloid or ICG.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Radboudumc | Nijmegen | Gelderland | Netherlands | 6525 GA |
Sponsors and Collaborators
- Radboud University Medical Center
- Philips Healthcare
- Johnson & Johnson
Investigators
- Principal Investigator: Erik HF van der Heijden, Dr., Radboud University Medical Center
- Study Director: Desi KM ter Woerds, MSc., Radboud University Medical Center
- Study Director: Roel LJ Verhoeven, Dr., Radboud University Medical Center
- Study Director: Erik HJ Aartnzen, Dr., Radboud University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Gilmore DM, Khullar OV, Colson YL. Developing intrathoracic sentinel lymph node mapping with near-infrared fluorescent imaging in non-small cell lung cancer. J Thorac Cardiovasc Surg. 2012 Sep;144(3):S80-4. doi: 10.1016/j.jtcvs.2012.05.072. Epub 2012 Jun 20.
- Rena O, Boldorini R, Papalia E, Turello D, Massera F, Davoli F, Roncon A, Baietto G, Casadio C. Metastasis to subsegmental and segmental lymph nodes in patients resected for non-small cell lung cancer: prognostic impact. Ann Thorac Surg. 2014 Mar;97(3):987-92. doi: 10.1016/j.athoracsur.2013.11.051. Epub 2014 Jan 28.
- Sun WYL, Dang JT, Modasi A, Nasralla A, Switzer NJ, Birch D, Turner SR, Karmali S. Diagnostic accuracy of sentinel lymph node biopsy using indocyanine green in lung cancer: a systematic review and meta-analysis. Gen Thorac Cardiovasc Surg. 2020 Sep;68(9):905-913. doi: 10.1007/s11748-020-01400-8. Epub 2020 Jun 16.
- Taghizadeh Kermani A, Bagheri R, Tehranian S, Shojaee P, Sadeghi R, N Krag D. Accuracy of sentinel node biopsy in the staging of non-small cell lung carcinomas: systematic review and meta-analysis of the literature. Lung Cancer. 2013 Apr;80(1):5-14. doi: 10.1016/j.lungcan.2013.01.001. Epub 2013 Jan 23.
- 113036
- NL81008.000.22