NCT03968679

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
26mo left

Started Jul 2019

Longer than P75 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jul 2019Jul 2028

First Submitted

Initial submission to the registry

May 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2026

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Expected
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

6.5 years

First QC Date

May 27, 2019

Last Update Submit

February 2, 2026

Conditions

Head and Neck Cancer

Keywords

head and neck cancerlymph drainage mappingsentinel node procedureradiotherapyunilateral elective neck irradiation

Outcome Measures

Primary Outcomes (1)

  • Contralateral regional failure

    Cumulative incidence of contralateral regional metastasis.

    1 year

Secondary Outcomes (2)

  • Treatment toxicity

    Until 2 years after end of radiotherapy

  • Health-related quality of life

    Until 18 months after end of radiotherapy

Study Arms (1)

Unilateral elective nodal irradiation

EXPERIMENTAL

Exclusion of contralateral neck from elective nodal irradiation, based on results of SPECT/CT and (in case of contralateral drainage) contralateral sentinel node procedure.

Radiation: Unilateral elective nodal irradiation

Interventions

Unilateral elective nodal irradiationRADIATION

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.

Unilateral elective nodal irradiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

Related Publications (1)

  • de 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: 31727019DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Abrahim Al-Mamgani, MD, PhD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2019

First Posted

May 30, 2019

Study Start

July 22, 2019

Primary Completion

January 14, 2026

Study Completion (Estimated)

July 1, 2028

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)