The American College of Radiology Imaging Network (ACRIN) has activated a multicenter trial of FDG PET/CT staging of head and neck cancer and its impact on the N0 neck surgical treatment in head and neck cancer patients.
The objective of the trial is to determine the negative predictive value of FDG PET/CT for staging the N0 neck based upon pathological sampling of the neck lymph nodes and to determine PET/CT’s potential to change treatment of the N0 neck patient.
The principal investigator of the trial is Val J. Lowe, MD, professor of radiology, division of nuclear medicine at Mayo Clinic, Rochester, Minn., and a total of 292 participants will be enrolled from a minimum of 10 ACRIN-qualified institutions, for approximately two years.
Participants include people with newly diagnosed head and neck squamous cell carcinoma being considered for surgical resection, with at least one side of the neck clinically N0, and at risk for occult metastasis (when risk based on clinical data is felt to be greater than 30 percent), said the ACRIN.
The surgeon will have access to the FDG PET/CT results prior to the surgical procedure in the trial. The data will demonstrate how the inclusion of the FDG PET/CT imaging will affect the determination of extent of disease, disease characterization and prognosis, and the surgical plan originally devised from clinical nodal assessment and CT or MRI results, added the ACRIN.
The trial also will analyze quality of life assessments and cost effectiveness, according to ACRIN, along with a correlation between FDG-PET/CT imaging and biomarker data in the same patient group for early disease detection and to decrease treatment costs.