A Pilot Feasibility Study of PET-CT Imaging in Patients With Cancer of the Head and Neck Treated With Definitive Chemoradiation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Prognostic value of positron emission tomography-computed tomography imaging in predicting clinical response at baseline, at weeks 2 and 4, and at week 6 post chemoradiotherapy
Study Overview
Brief Summary
RATIONALE: Imaging procedures, such as PET scan and CT scan, may help doctors predict a patient's response to treatment and plan the best treatment.
PURPOSE: This clinical trial is studying how well PET scans and CT scans show response to treatment in patients with locally advanced head and neck cancer undergoing chemotherapy and radiation therapy.
Detailed Description
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Prognostic value of positron emission tomography-computed tomography imaging in predicting clinical response at baseline, at weeks 2 and 4, and at week 6 post chemoradiotherapy
Time Frame: 3 months
The results of the experimental scans will be compared to the response to radiation therapy as measured by routine scans at 6 weeks and 3 months after completion of therapy
Secondary Outcomes
No secondary outcomes reported
