Download ACRIN seeks sites for the clinical trial: “A Multicenter Trial of FDG

Dear Dr. / Drs. [name of physician(s)]
I am writing to inform you about a clinical trial “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 Patient” (ACRIN 6685) that [is soon to open / has opened] at
[name of institution] on [date]. The trial’s aim is to evaluate FDG-PET for staging the
clinically-defined negative neck (N0-neck) based upon pathological sampling of the neck
lymph nodes and its impact on the surgical treatment of the N0 neck patient.
The trial is sponsored by the American of Radiology Imaging Network (ACRIN) a
member of the National Cancer Institute’s Clinical Trial Cooperative Group program and
is led by the national principal investigators Val J. Lowe, MD of the Mayo Clinic,
Rochester, MN, and Brendan C. Stack, Jr., MD, FACS of the University of Arkansas for
Medical Sciences, Little Rock, AR. The trial was reviewed and approved by the NCI’s
Cancer Therapy Evaluation Program and by the American College of Radiology’s
institutional review board.
Greater understanding of when FDG–uptake negative necks are pathologically negative,
and vice versa, could potentially benefit head and neck patients presenting with clinically
N0 necks, offering some patients the opportunity to forgo unneeded neck treatment. In
addition to assessing FDG-PET findings’ impact on patient management, the trial’s
secondary aims include quality of life and cost effectiveness analysis of PET/CT in this
indication.
Patients eligible for this trial are newly diagnosed with head and neck squamous cell
carcinoma and are 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%). [name of institution] is one of 15 sites in the United States
participating in the trial and a total of 292 participants will be enrolled within a target 24
month accrual time.
Thank you for your consideration of trial support.