Clinical trial · Interventional
Lymph Drainage Mapping for Tailoring Elective Nodal Irradiation in Head and Neck Cancer
Mapping of Sentinel Lymph Node Drainage Using SPECT/CT to Tailor Highly Selective Elective Nodal Irradiation in Node-negative Neck of Patients With Head and Neck Cancer
- 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 aims to explore the safety and outcome of lymph drainage mapping(LDM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only. The goal is to exclude the contralateral negative neck from the irradiation fields when there is no contralateral draining sentinel node. In case contralateral lymph drainage is found on SPECT/CT, a contralateral sentinel node procedure (SNP) is performed to remove the draining node. The patient will only receive contralateral ENI if (micro/macro)metastasis are found in this contralateral sentinel node.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Unilateral elective nodal irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Unilateral elective nodal irradiation
- description
- Exclusion of contralateral neck from elective nodal irradiation, based on results of SPECT/CT and (in case of contralateral drainage) contralateral sentinel node procedure.
- interventionNames
- Radiation: Unilateral elective nodal irradiation
Primary outcomes (1)
- measure
- Contralateral regional failure
- timeFrame
- 1 year
- description
- Cumulative incidence of contralateral regional metastasis.
Secondary outcomes (2)
- measure
- Treatment toxicity
- timeFrame
- Until 2 years after end of radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed and histopathologically proven primary HNSCC * T1-4N0-2b * Tumor does not cross midline * WHO performance status 0 or 1 * Signed written informed consent Exclusion Criteria: * Distant metastatic spread at the time of inclusion * Chemotherapy or surgery (for the present tumor), prior to inclusion * Previous radiation treatment in the head and neck region, for any reason * Previous neck dissection * Recurrent or second primary tumor in the head and neck region * Head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus * Pregnancy or no active contraception for pre-menopausal women * Known hypersensitivity to iodine or nanocolloid injection * Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow-up schedules
References
Publications (1)
- DERIVEDde Veij Mestdagh PD, Schreuder WH, Vogel WV, Donswijk ML, van Werkhoven E, van der Wal JE, Dirven R, Karakullukcu B, Sonke JJ, van den Brekel MWM, Marijnen CAM, Al-Mamgani A. Mapping of sentinel lymph node drainage using SPECT/CT to tailor elective nodal irradiation in head and neck cancer patients (SUSPECT-2): a single-center prospective trial. BMC Cancer. 2019 Nov 14;19(1):1110. doi: 10.1186/s12885-019-6331-8. PMID 31727019