Mapping of Sentinel Lymph Node Drainage Using SPECT (SUSPECT) (SUSPECT)

Netherlands Cancer Institute (NKI)

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Radiation: radiation in Squamous Head and Neck Cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT02572661

NL51706.031.14 (Registry Identifier)

N14SUS (Registry Identifier)

Details and patient eligibility

About

This study aims to explore the feasibility, safety and outcome of a non-invasive sentinel node mapping (SNM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only and to exclude the contralateral negative neck from the irradiation fields when there is no draining sentinel node. Subsequently the dose to the salivary glands, mucosal area and the swallowing and chewing muscles and structures involved in voicing and articulation will significantly be reduced

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed patients with histopathologic proven primary HNSCC (T1 -3 N0 -1) located in the oral cavity, oropharynx, larynx (except T1 glottic ), and hypopharynx, not crossing the midline and planned for treatment with (chemo)radiotherapy in curative setting
• No chemotherapy or surgery prior to inclusion
• No distant metastatic spread at the time of inclusion
• Age ≥ 18 years
• WHO performance status 0 or 1
• Signed written informed consent

Exclusion criteria

• Patients with previously radiation treatment in the head and neck region, for any reason
• Patients with previous neck dissection
• Patients with recurrent or second primary tumor in the head and neck region
• Patients with head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus
• Previous history of cancer in the last five years (excluding basal cell carcinoma of the skin and in situ SCC of the cervix)
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Squamous Head and Neck Cancer

Other group

Description:

radiation

Treatment:

Radiation: radiation in Squamous Head and Neck Cancer