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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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).

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.
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: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter will be the detection rate of sentinel lymph nodes<br /><br>with MR lymphography compared to conventional sentinel lymph node scintigraphy<br /><br>using 99mTc-nanocolloid. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To compare the number of MR lymphographic detected SLNs with those detected<br /><br>by means of 99mTc-nanocolloid lymphoscintigraphy on a per-subject basis.<br /><br>• To compare histopathologic assessment (presence or absence of metastasis) of<br /><br>the excised lymph node(s) detected by conventional preoperative<br /><br>99mTc-nanocolloid lymphoscintigraphy and intraoperative gammaprobe<br /><br>localization, with the SLNs identified by means of preoperative MR lymphography.<br /><br>• Observing contralateral drainage patterns in lateralized tumors and compare<br /><br>these patterns between MR lymphography and conventional 99mTc-nanocolloid<br /><br>lymphoscintigraphy.<br /><br>• To assess pairwise inter-observer agreements between MR lymphography and<br /><br>conventional 99mTc-nanocolloid lymphoscintigraphy regarding preoperative SLN<br /><br>detection.</p><br>