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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03968679

Acronym

SUSPECT-2

Enrollment

Registered

2019-05-30

Start date

2019-07-22

Completion date

2028-07-01

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

head and neck cancer, lymph drainage mapping, sentinel node procedure, radiotherapy, unilateral elective neck irradiation

Brief summary

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.

Detailed description

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.

Interventions

RADIATIONUnilateral elective nodal irradiation

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Contralateral regional failure	1 year	Cumulative incidence of contralateral regional metastasis.

Secondary

Measure	Time frame	Description
Treatment toxicity	Until 2 years after end of radiotherapy	Physician-rated early and late treatment toxicity (CTCAE v5.0)
Health-related quality of life	Until 18 months after end of radiotherapy	Health-related quality of life after treatment (EORTC QLQ-C30/HN35)

Countries

Netherlands

Contacts

PRINCIPAL_INVESTIGATORAbrahim Al-Mamgani, MD, PhD

The Netherlands Cancer Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026