Sentinel lymph node detection in early-stage ORal Cavity squamous cell carcinoma using Magnetic Resonance (MR) lymphogrAphy - ORCA

niversitair Medisch Centrum Utrecht0 sites10 target enrollmentStarted: TBDLast updated: April 15, 2024

Conditions

Trial Snapshot

No summary available.

•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 T1-T2 and
•T3 (only when T3 is assessed based on tumor dimensions of >2 cm and <=4 cm with
•DOI >10 mm), N0, M0 (see Appendix 3: TNM Staging).
•3. Clinical nodal staging (N0) has been confirmed by negative results from CT,
•MRI, PET/CT and/or ultrasound guided fine needle aspiration cytology within 30
•days of the SLNB procedure.
•4. The patient is a candidate for transoral excision and sentinel lymph node
•5. The patient has given informed consent for a surgical procedure regarding
•his/her oncological treatment.
•6. Patients with prior malignancy are allowed, provided the patient meets both
•of the following criteria:
•Underwent potentially curative therapy for all prior head and neck
•malignancies and is deemed low risk for recurrence; and
•No head and neck malignancy for the past five years and no evidence of
•recurrence.
•7. The patient is >=18 years of age at the time of consent.
•8. The patient has an ECOG status of Grade 0 - 2 (see Appendix 4: Performance
•Status 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 is pregnant.
•3. Patient is incapacitated.
•4. Previous allergic reaction after administration of a gadolinium-based
•contrast agent for contrast enhanced MR imaging.
•5. The patient has clinical or radiological evidence of metastatic cancer to
•the regional lymph nodes.
•6. The patient has a history of neck dissection, or gross injury to the neck
•that would preclude reasonable surgical dissection for this trial, or
•radiotherapy to the neck.
•7. The patient is actively receiving systemic cytotoxic chemotherapy.
•8. Patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.
•9. Patient has severe renal impairment (eGFR<30).
•10. Participation will result in unacceptable delay regarding oncological
•11. Patients with known claustrophobia, who are as a consequence unable to
•undergo MR imaging.

Sponsor

niversitair Medisch Centrum Utrecht