Lymph Drainage Mapping for Tailoring Elective Nodal Irradiation in Head and Neck Cancer (SUSPECT-2)
February 2, 2026 updated by: The Netherlands Cancer Institute
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
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Amsterdam, Netherlands, 1066 CX
- Netherlands Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Unilateral elective nodal irradiation
Exclusion of contralateral neck from elective nodal irradiation, based on results of SPECT/CT and (in case of contralateral drainage) contralateral sentinel node procedure.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Contralateral regional failure
Time Frame: 1 year
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Cumulative incidence of contralateral regional metastasis.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment toxicity
Time Frame: Until 2 years after end of radiotherapy
|
Physician-rated early and late treatment toxicity (CTCAE v5.0)
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Until 2 years after end of radiotherapy
|
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Health-related quality of life
Time Frame: Until 18 months after end of radiotherapy
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Health-related quality of life after treatment (EORTC QLQ-C30/HN35)
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Until 18 months after end of radiotherapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Abrahim Al-Mamgani, MD, PhD, The Netherlands Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2019
Primary Completion (Actual)
January 14, 2026
Study Completion (Estimated)
July 1, 2028
Study Registration Dates
First Submitted
May 27, 2019
First Submitted That Met QC Criteria
May 29, 2019
First Posted (Actual)
May 30, 2019
Study Record Updates
Last Update Posted (Actual)
February 4, 2026
Last Update Submitted That Met QC Criteria
February 2, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M19SUS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.