EUCTR2021-003554-23-NLActive, not recruitingPhase 1
Sentinel lymph node detection in early-stage ORal Cavity squamous cellcarcinoma using Magnetic Resonance (MR) lymphogrAphy - ORCA
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 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 biopsy.
- •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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
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 is pregnant or lactating.
- •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 treatment.
- •11. Patients with known claustrophobia, who are as a consequence unable to undergo MR imaging.
Investigators
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