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

NCT02572661 | Completed DMC

• 2 other identifiers: N14SUSNL51706.031.14
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Cancer

Keywords

Radiotherapy, Sentinel Node Mapping, Spect

Outcome Measures

Primary Outcomes (1)

• Feasibility and safety of single side radiation therapy measured by physical examination and toxicity measurement by CTCAE 4.03 at 12 weeks

  mapping of sentinel lymph node drainage to indentify groups at low risk of the probability of contra regionale failure is to be estimated to be 2% at 2 years. A recurrrence rate of \>15% will be assumed unacceptable

  12 weeks

Study Arms (1)

Squamous Head and Neck Cancer

OTHER

radiation

Radiation: radiation in Squamous Head and Neck Cancer

Interventions

radiation in Squamous Head and Neck Cancer RADIATION

Squamous Head and Neck Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age ≥ 18 years
• WHO performance status 0 or 1
• Signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

the Netherlands Cancer Instiute

Amsterdam, 1066 CX, Netherlands

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Physical Phenomena

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: December 22, 2014
• First Posted: October 9, 2015
• Study Start: July 23, 2015
• Primary Completion: November 9, 2018
• Study Completion: November 9, 2018
• Last Updated: June 27, 2019

Record last verified: 2019-06

Locations

NL (1)