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
Protocol-ACRIN 6685 Amendment 8 v06.29.2015 [PDF]
SOC-Protocol-ACRIN 6685 Amendment 8 v06.29.2015 [PDF]
Informed Consent-ACRIN 6685 v06.29.2015 [DOC]
Protocol-ACRIN 6685 Amendment 7 (SOC Cover Page), v2.26.2014 [PDF]
Informed Consent-ACRIN 6685 [DOC]
Val J. Lowe, MD and Brendan C. Stack, Jr., MD, FACS
Main Objective: The objective of this study is to determine the negative predictive value
of PET/CT for the N0 neck based upon pathologic sampling of the neck lymph nodes and to
determine PET/CT’s potential to change treatment of the N0 neck.
Participants: People with newly diagnosed head and neck squamous cell carcinoma being
considered for surgical resection, with at least one side of the neck planned for dissection clinically
N0, and at risk for occult metastasis (when risk based on clinical data is felt to be greater than 30%).
Study Design Summary: A total of 292 participants will be enrolled from a minimum of
10 ACRIN-qualified institutions, enrolling for approximately 24 months.