oral cancer
Conditions
Interventions
The study population will receive peritumoral injections of superparamagnetic
iron oxide nanoparticles (SPIO) and afterwards a pre-operative MRI lymphography
will be performed to locate the sentinel
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the diagnostic accuracy, in terms of sensitivity and negative predictive value, of a complete magnetic SLNB procedure (SPIO peritumoral injections, preoperative SPIO-enhanced MRI and SLN harvesting using a magnetometer) and the additional value of the magnetic SLNB procedure to the radioactive (conventional) SLNB. Results of the complete magnetic SLNB will be evaluated and compared with the reference standard, i.e. histopathological examination of SLNs and complementary neck dissection specimens as well as 12 months follow-up. False-negative SLNB outcomes of included patients will be scored. False-negative rates (false-negative/(false-negative + true-positive)) following each SLNB technique and the combination will be calculated and presented in percentages. If a positive SLN is missed by one of the techniques (but depicted by the other technique) this SLN is considered false-negative for this technique. Using the false-negative rates, the sensitivity (true-positive/(true-positive + false-negative)) and NPVs (true-negative/(true-negative + false-negative)) will be calculated accordingly for each technique separately and combined. | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection rate (in percentages) of SLN(s) with SPIO-enhanced MR lymphoscintigraphy as compared to conventional lymphoscintigraphy using 99mTc-nanocolloid with histopathology as the reference standard as well as 12 months follow-up. The number of SLNs identified for each subject will be recorded, and summary statistics (mean, median, standard deviation, minimum, and maximum) on the number of SLNs will be displayed. The pathological status of SLNs will be assessed on a per subject basis. The number and percentages of subjects who have at least one histopathological-positive SLN will be calculated. | — |
Countries
Netherlands
Outcome results
None listed