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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-23

Study Completion Date

2018-11-09

Brief Summary

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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

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Squamous Head and Neck Cancer

radiation

Group Type OTHER

radiation in Squamous Head and Neck Cancer

Intervention Type RADIATION

Interventions

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radiation in Squamous Head and Neck Cancer

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No