Sentinel lymph node detection and staging in early-stage oral cancer using superparamagnetic iron oxide nanoparticles

• Conditions: oral cancer; 10027476; 10019190

• Registration Number: NL-OMON51639
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 82

Inclusion Criteria

1. The patient has provided written informed consent authorization before
participating in the study.
2. The patient has a diagnosis of primary oral squamous cell carcinoma that is
anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge,
upper alveolar ridge, retromolar gingival (retromolar trigone),
floor-of-the-mouth, hard palate or oral (mobile) tongue, and is stage cT1-T2
and T3 (only when T3 is assessed based on tumor dimensions of >2 cm and <=4 cm
with DOI >10 mm) (see Appendix 3: Tumor Nodal Metastasis (TNM) Staging).
3. Clinical nodal staging (cN0) has been confirmed by at least ultrasound, with
in case of suspicious lymph nodes ultrasound guided fine-needle aspiration
cytology, CT and/or MRI within 30 days of the SLNB procedure.
4. The patient is a candidate for transoral excision.
5. Patients with prior malignancy of the head and neck area are allowed,
provided the patient meets both of the following criteria:
a. Underwent potentially curative therapy for all prior head and neck
malignancies and is deemed low risk for recurrence; and
b. No head and neck malignancy for the past three years and no evidence of
recurrence.
6. The patient is >=18 years of age at the time of consent.
7. The patient has an ECOG status of Grade 0 - 2 (see Appendix 4: Performance
Status Criteria).

Exclusion Criteria

1. The patient has a diagnosis of squamous cell carcinoma of the head and neck
in the following anatomical areas: non-mobile base of the tongue, oropharynx,
nasopharynx, hypopharynx, and larynx.
2. The patient has clinical or radiological evidence of metastatic cancer to
the regional lymph nodes.
3. The patient has a history of neck dissection, or gross injury to the neck
that would pre-clude reasonable surgical dissection for this trial, or
radiotherapy to the neck.
4. The patient is incapacitated.
5. The patient has had an intolerance or hypersensitivity to iron or dextran
compounds, Magtrace® or lidocaine.
6. The patient has an iron overload disease.
7. The patient has an active implantable device in the upper body.
8. The patient is known with claustrophobia, who are a consequence unable to
undergo MR imaging.
9. The patient has a contra-indication for MR imaging (e.g. metal implant).
10. The patient is pregnant.
11. Participation will result in unacceptable delay regarding oncological
treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified