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NCT Number: NCT03968679

Lymph Drainage Mapping for Tailoring Elective Nodal Irradiation in Head and Neck Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

About this study

The SUSPECT2 study is a modified concept from the first SUSPECT study (N14SUS). The first study investigated whether lymph drainage mapping (LDM) using SPECT/CT was a safe and feasible method to exclude the contralateral neck from irradiation, or, in case of contralateral lymph drainage, to tailor the contralateral ENI field to the level containing the tracer accumulation. In this study, large dose reductions to most organs at risk were realized, as well as significant reductions of both short term (mucositis, dysphagia) and long term (xerostomia, dysphagia) toxicities.

Firstly, the SUSPECT2 study aims to expand the inclusion criteria of the original SUSPECT study. Secondly, it aims to further reduce the proportion of patients that undergoes bilateral ENI, by performing a contralateral sentinel node procedure (SNP) in case of contralateral lymph drainage. The patient will only receive contralateral ENI if (micro/macro)metastasis are found in this contralateral sentinel node.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unilateral elective nodal irradiation

Radiation

After injection of nanocolloid tracer submucosally around the tumor, patients undergo lymph drainage mapping (LDM) using SPECT/CT. If no contralateral drainage is visualized, the patient receives unilateral elective nodal irradiation (ENI). In case of contralateral lymph drainage, a contralateral sentinel node procedure is performed. If pathologic evaluation finds no metastasis, the patient receives unilateral ENI. If (micro/macro) metastasis are found, the patient will receive bilateral ENI.

Primary outcomes

  1. Contralateral regional failure

    Time frame: 1 year

    Cumulative incidence of contralateral regional metastasis.

Secondary outcomes

  1. Treatment toxicity

    Time frame: Until 2 years after end of radiotherapy

    Physician-rated early and late treatment toxicity (CTCAE v5.0)

  2. Health-related quality of life

    Time frame: Until 18 months after end of radiotherapy

    Health-related quality of life after treatment (EORTC QLQ-C30/HN35)

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Collaborators

  • Radboud University Medical Center

Registry information

Official study title

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

Acronym: SUSPECT-2

Important dates

Study start
2019
Primary completion
2026
Study completion
2028
First posted
May 30, 2019
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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