Identification of lymphatic metastasis in patients with oral cavitysquamous cell carcinoma by means of MR lymphography

Phase 1

• Conditions: The IMP will be used for the identification of sentinel lymph node(s) in patients with early-stage oral cavity squamous cell carcinoma and a clinically negative neck (T1-3, N0, M0).; MedDRA version: 20.0Level: LLTClassification code 10072873Term: Sentinel lymph node mappingSystem Organ Class: 100000004848; MedDRA version: 20.1Level: LLTClassification code 10004822Term: Biopsy of lymph nodeSystem Organ Class: 100000004848; MedDRA version: 21.0Level: LLTClassification code 10030961Term: Oral cancer stage unspecifiedSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2021-003554-23-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-27
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified