Clinical trial · Interventional
Sentinel Node in Larynx and Pharynx Cancers
Sentinel Node Localization in Larynx and Pharynx Cancers After Flexible Endoscopy-guided Tracer Injection: a Feasibility Study.
NCT04068636CI-TRIAL-00058157FLEX-NODEcompletedN/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)
This study explores the feasibility of sentinel lymph node identification in pharynx and larynx cancers using flexible endoscopy-guided tracer injection.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lymph Node Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Flexible endoscopy guided SNB in larynx and pharynx cancers.
- description
- Patients with larynx and pharynx cancers will undergo sentinel node biopsy via flexible endoscopy. In this procedure, a radioactive tracer will be injected at 2-4 sites edging the tumor. A SPECT scan will be performed for visualization of the sentinel node(s).
- interventionNames
- Procedure: Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes.
Primary outcomes (1)
- measure
- Generation of SPECT-images of sufficient quality for localization of the sentinel node(s) after peritumoral Tc-99m-nanocolloid injection guided by flexible endoscopy.
- timeFrame
- The data of each patient will be assessed within 6 months.
- description
- All SPECT images will be assessed qualitatively by concerted consensus between a nuclear medicine physician, head and neck surgeons and a radiation oncologist. Aspects that will be evaluated include: * Is there sufficient uptake of tracer for identification and localization of lymph nodes? * Does tracer uptake in primary tumor interfere with lymph node identification? * Is sentinel lymph node localization consistent with what can be expected with normal, undisturbed lymph node drainage and what is known from the literature?
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female aged \>18 years. * Mucosal tumor of the oropharynx, hypopharynx or larynx. * Patients planned to undergo biopsy via flexible endoscopy. * Patients planned to undergo curative radiotherapy with or without concurrent chemotherapy. * Patient provided written informed consent. Exclusion Criteria: * Patients who underwent previous surgery or radiotherapy to the neck. * Patients with airway obstruction causing stridor. * Prior allergic reaction to Tc-99m-nanocolloïd. * Pregnancy. * Unable to provide informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.