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NCT03968679Active, not recruiting

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 · Last updated 4 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
27 May 2019
Start date
22 Jul 2019
Primary completion date
14 Jan 2026
Lead sponsor
The Netherlands Cancer Institute
NCT number
NCT03968679

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From 22 Jul 2019 to the primary completion date, 14 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus
  • Known hypersensitivity to iodine or nanocolloid injection
  • Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow-up schedules

Other

  • Distant metastatic spread at the time of inclusion
  • Recurrent or second primary tumor in the head and neck region
  • Pregnancy or no active contraception for pre-menopausal women

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Netherlands Cancer Institute
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.