NL-OMON51639Not yet recruitingNot Applicable
Sentinel lymph node detection and staging in early-stage oral cancer using superparamagnetic iron oxide nanoparticles - MAGNETICS
niversitair Medisch Centrum Utrecht0 sites82 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 82
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
Investigators
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