Clinical Value of Combined [18F]Fluoro-2-deoxy-D-glucose (FDG) PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Potentially Operable Locally Advanced Head and Neck Squamous Cell Carcinoma.
Patients with locally advanced, N2 and N3 head and neck squamous cell carcinoma (HNSCC) will
be recruited. All subjects receiving induction chemotherapy will undergo a baseline
integrated [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed
tomography (PET/CT) scan before the start of concurrent chemoradiation. This baseline
assessment is optional in patients not receiving neo-adjuvant treatment.
All patients will undergo a dedicated FDG PET/CT protocol 12 weeks after the end of
chemoradiation (primary endpoint). In PET/CT negative patients, 2 monthly control visits
will be performed complemented with additional imaging as required. All patients will
undergo PET/CT 1 year after completing chemoradiation unless recurrent/residual disease was
already proven pathologically. Patients with a PET/CT suspected for residual nodal disease
must have pathological proof of nodal involvement (fine needle aspiration in non-operable
patients or neck dissection in the others) before salvage chemotherapy is started.
In a subset of patients receiving induction chemotherapy prior to concurrent chemoradiation,
an additional FDG PET/CT scan will be performed at baseline and after 1 cycle of
chemotherapy to evaluate the metabolic response to the treatment (secondary endpoint).
Observational Model: Cohort, Time Perspective: Prospective
Negative predictive value (NPV) of FDG PET/CT
The negative predictive value (NPV) of FDG PET/CT for detecting residual nodal involvement
12 weeks after chemoradiation
Sigrid Stroobants, MD, PhD
University Hospital, Antwerp
Belgium: Ethics Committee