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Clinical Trials/NCT00388024
NCT00388024CompletedNot Applicable

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

Wake Forest University Health Sciences1 site in 1 country19 target enrollmentStarted: February 2006Last updated:
Conditions

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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