Oral squamous cell carcinoma Oral cancer
Conditions
Interventions
FDG-PET/CT + contrast CT hals.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must meet all of the following criteria: • Newly diagnosed early-stage OSCC is defined as clinically T1-3, N0 (only when T3 is assessed based on tumor dimensions of >2 cm and 10 mm) • The patient is >=18 years of age at the time of consent. • The patient has no palpable lymph nodes in the neck. • Clinical nodal staging (cN0) has been confirmed by ultrasound, CT, and/or MRI if performed (not mandatory). • The patient is a candidate for transoral excision and SLNB. • The patient has provided written informed consent authorization before participating in the study. • 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.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • The patient has other pathologies than squamous cell carcinoma; • The patient has a history of treatment of the neck (neck dissection and/or radiotherapy); • The patient has ultrasound guided fine needle aspiration cytology positive for lymph node metastasis; • The patient has poorly controlled diabetes mellitus; • The patient refused preoperative imaging workups. A potential subject who meets the following criteria will only be excluded for the contrast-enhanced CT of the head and neck: • The patient has had a previous allergic reaction after administration of contrast fluid. • Impaired renal function (eGFR =30 mL/min/1.73 m²) • When it is logistically not feasible to schedule a contrast-enhanced CT of the neck alongside the FDG-PET/CT prior to surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to reduce the need for SLNB by FDG-PET/CT + contrast enhanced CT of the neck in cN0 OSCC patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To optimize scoring criteria for the detection of (occult) lymph node metastases by FDG-PET/CT (+ contrast enhanced CT of the neck) with a high positive predictive value. • To assess the sensitivity, specificity, PPV, negative predictive value and accuracy for the different scoring criteria. • To investigate inter-observer agreement before and after scoring criteria are established. • To compare the quality of life and costs in three different diagnostic scenarios 1) PET/CT, 2) SLNB, and 3) PET/CT and, only if negative, SLNB. • To obtain insight into patients* preferences and experience of the diagnostic procedures. | — |
Countries
Netherlands
Contacts
Public ContactR. Bree
Universitair Medisch Centrum Utrecht
Outcome results
None listed