Trial Information

A Pilot Feasibility Study of PET-CT Imaging in Patients With Cancer of the Head and Neck Treated With Definitive Chemoradiation

OBJECTIVES:

Primary

- Determine the feasibility of performing positron emission tomography-computed
tomography (PET-CT) imaging for early discrimination of treatment response and
post-therapy neck management in patients with locally advanced cancer of the head and
neck treated with definitive chemoradiotherapy.

Secondary

- Perform semiquantitative analysis of tracer uptake in these patients using standard
uptake values and qualitative analysis of tracer uptake using pure visual analysis.

- Determine the feasibility of distinguishing benign from malignant processes during
initial tumor staging of these patients by whole-body PET-CT imaging.

- Correlate staging by whole-body PET-CT imaging with staging by standard CT/MRI,
clinical exam, and pathologic specimen.

- Determine the feasibility of PET-CT imaging in these patients in treatment position for
radiotherapy treatment planning, correlate the results with standard CT/MRI images, and
record the differences.

- Perform PET-CT imaging in these patients during weeks 2 and 4 of chemoradiotherapy to
evaluate the predictive value of response to treatment at these time points.

- Determine if the time interval for treatment monitoring at 6 and 12 weeks post
chemoradiotherapy is important for the predictive value of PET-CT imaging.

- Evaluate patients with clinical or radiographic abnormalities worrisome for residual or
recurrent disease with PET-CT imaging at 6 and 12 weeks post chemoradiotherapy to
assess the need for additional therapies (i.e., neck dissection).

OUTLINE: This is a pilot study.

Patients receive fludeoxyglucose F 18 (FDG) IV over 90 seconds prior to the initial scan.
Patients undergo whole-body computed tomography (CT) imaging with contrast followed by
positron emission tomography (PET) imaging (approximately 1 hour after FDG injection) for
initial staging and simulation for radiotherapy treatment planning. After PET-CT evaluation,
patients with locoregional disease are recommended for standard-care chemoradiotherapy.
Patients with evidence of M1 disease that is confirmed by CT/MRI and/or biopsy are treated
at the discretion of the attending clinician. During chemoradiotherapy, patients undergo
PET-CT imaging, as described above, at the beginning of week 2 and during week 4 for
treatment monitoring and early detection of recurrent or residual disease. Follow-up PET-CT
scans are performed, as described previously, at 6 weeks and then at 3 months after
completion of chemoradiotherapy.

After completion of study procedures, patients are followed periodically for up to 5 years.