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.

Study ID
STU 032016-081

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Clements University Hospital

Contact
Ayobami Odu
214/648-5474
Ayobami.Odu@UTSouthwestern.edu

Principal Investigator
William Moore

Summary

This protocol is a prospective, multicenter trial using FDG-PeT/CT to assess patients with newly diagnosed head and neck SCC, who are being considered for surgical resection, with at least one side of the neck planned for dissection clinically n0.

Participant Eligibility

Inclusion Criteria
5.1.1 Participant > 18 years of age;
5.1.2 Participant with histologic confirmation of newly diagnosed SCC of the head and neck;
5.1.3 Participant with unilateral or bilateral neck dissection planned for care. An N0 neck must be planned to be dissected for the patient to be eligible. The N0 neck can be either ipsilateral to the head and neck tumor or the contralateral N0 neck if a bilateral neck dissection is planned;
5.1.4 Participant with confirmed head and neck SCC;
5.1.5 CT and/or MR imaging has been completed within six (6) weeks prior to enrollment, even if the SCC diagnosis has been made via other methods, and will be submitted to ACRIN;
5.1.6 Simultaneous diagnostic CT with PET will not be excluded, but in such cases PET cannot be used as part of the criteria to define the N0 neck as required for entrance to the trial;
5.1.7 If sites received CT and/or MR images from institutions other than their own, ACRIN recommends a re-read by a local neuroradiologist to ensure compliance with protocol eligibility requirements.
5.1.8 Participant with at least one neck that is clinically N0 as defined by clinical exam (physical exam with CT and/or MRI as the gold standard of the N0 neck); Stages T2, T3, or T4. N0xN3, excluding N2c for bilateral disease based on criteria from the American Joint Commission on Cancer34 (available through the National Comprehensive Cancer Network www.nccn.org/professionals/physician_gls/PDF/head-and-neck.pdf; web site
registration required);
5.1.8 Participant in whom it may be considered a viable clinical option to perform neck dissection when primary cancers are at high risk for neck metastasis (see definition above);
5.1.9 These will include: 1) oral cavity cancer; 2) oropharynx cancer, including base of tongue and tonsil cancers; 3) larynx cancer; or 4) supraglottic cancer.
5.1.10 Participant willing to provide a written informed consent.