The American College of Radiology Imaging Network (ACRIN) has started a multicenter trial designed to assess the value of FDG-PET/CT staging for head and neck cancer patients.
The trial, ACRIN 6685, is designed to focus on the impact of PET/CT for staging patients with head and neck cancer that does not initially appear to have spread to the lymph nodes, also known as N0 neck patients. About 25% to 30% of N0 negative neck patients are found to have metastatic neck nodes at surgery, a finding that decreases overall survival by about 50%.
The trial, led by Dr. Val Lowe of the Mayo Clinic in Rochester, MN, is designed to determine the predictive value of FDG-PET/CT for staging N0 patients based on pathological sampling of the neck lymph nodes, and determine the potential of FDG-PET/CT to change treatment of N0 neck patients.
Up to 15 participating sites are expected to accrue 292 study participants in approximately two years. Participants with newly diagnosed head and neck squamous cell carcinoma will undergo FDG-PET/CT imaging prior to surgical resection. The surgeon will have access to the FDG-PET/CT results prior to the surgical procedure.
The data will demonstrate how including the FDG-PET/CT imaging will affect the determination of disease extent, disease characterization, prognosis, and the surgical plan originally devised from clinical nodal assessment and CT or MRI results.
Ultimately, the study is expected to confirm that FDG-PET/CT images improve the characterization of N0 neck patients by accurately diagnosing N0 necks, better defining extent of primary disease, discovering unappreciated distant metastasis, and reducing morbidity.
Related Reading
ACRIN seeks research sites for clinical trial, November 6, 2009
ACRIN develops PET scanner program, July 15, 2009
AMI, ACRIN partner on PET registry development, February 7, 2005
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