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| ID | Type | Description | Link |
|---|---|---|---|
| NL81008.000.22 | Other Identifier | CCMO |
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| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
| Johnson & Johnson | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | One interventional arm that will undergo all interventional procedures (when applicable). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 99mTc-nanocolloid | Radiation | Injection of 99mTc-nanocolloid when lung cancer is diagnosed during a navigation bronchoscopy, followed by one or two SPECT/CT-scans. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of SLN procedure | 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. | During the study intervention |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik HF van der Heijden, Dr. | Radboud University Medical Center | Principal Investigator |
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | 6525 GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32557077 | Background | 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. | |
| 23352034 | Background |
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(Pseudonymized) metadata will be stored for reuse and/or verification.
Data will be accessible for an unknown time after publication of the results.
Under reasonable request.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This is a prospective, single-center, non-randomized, interventional study.
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|
| ICG | Drug | If patient undergoes surgery to treat the lung cancer, ICG will be injected and retrieved fluorescent lymph nodes will undergo additional pathological assessment. |
|
|
| 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 |
| 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. |
| 22726707 | Background | 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. |
| 24480258 | Background | 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |