An interventional study of 99mTc-nanocolloid and ICG in Early-stage Lung Cancer, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Diagnostic
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
One interventional arm that will undergo all interventional procedures (when applicable).
Radiation: 99mTc-nanocolloid · Drug: ICG
Injection of 99mTc-nanocolloid when lung cancer is diagnosed during a navigation bronchoscopy, followed by one or two SPECT/CT-scans.
Also known as: Elective navigation bronchoscopy, SLN procedure
If patient undergoes surgery to treat the lung cancer, ICG will be injected and retrieved fluorescent lymph nodes will undergo additional pathological assessment.
Also known as: Elective lung surgery, SLN procedure
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.
Time frame: During the study intervention
Successfulness of injection method (intra- or peritumoral)
Time frame: During the first intervention
Number of SLN found by SPECT/CT-imaging
Time frame: On the day of the first intervention
Number of SLN found by ICG
Time frame: On the day of the second intervention
Number of metastasis found by additional pathology
Time frame: Up to two weeks after the second intervention
Plan to share: Yes — (Pseudonymized) metadata will be stored for reuse and/or verification.
Supporting information: Study protocol
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center