Clinical trial · Interventional
Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify TDLN in Early-stage NSCLC
Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify Tumor Draining Lymph Nodes in Early-stage Lung Cancer
NCT05555199CI-TRIAL-00086239INITIATEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-stage Lung Cancer | Lung Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99mTc-nanocolloid | Radiation | — | UNRESOLVED |
| ICG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- One interventional arm that will undergo all interventional procedures (when applicable).
- interventionNames
- Radiation: 99mTc-nanocolloid
- Drug: ICG
Primary outcomes (1)
- measure
- Feasibility of SLN procedure
- timeFrame
- During the study intervention
- description
- 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 outcomes (4)
- measure
- Successfulness of injection method (intra- or peritumoral)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ASA physical status 1-3; * Lung lesion between 1 and 5 cm; * Imaging-based disease free lymph nodes (N0); * Patient is deemed a candidate for definitive lung tissue resection by a thoracic surgeon. Exclusion Criteria: * Pregnancy; * Inability to consent; * Known or suspected allergy to 99mTc-nanocolloid or ICG.
References
Publications (4)
- BACKGROUNDSun 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. PMID 32557077
- BACKGROUNDTaghizadeh 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. PMID 23352034
- BACKGROUNDGilmore 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. PMID 22726707
- BACKGROUNDRena 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. PMID 24480258