Positron Emission Tomography in Determining Stage of Esophageal Cancer
RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to determine the stage of esophageal cancer.
PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 positron emission tomography determines tumor stage in patients with esophageal cancer.
|Esophageal Cancer||Procedure: conventional surgery Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18 Drug: chemotherapy Radiation: Radiotherapy|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Carcinoma of the Thoracic Esophagus|
- Proportion of these patients with FDG-PET findings that contraindicate surgery [ Time Frame: Up to 1 month post-FDG-PET scan ]
- The proportion of false positive lesions found by FDG-PET. [ Time Frame: Up to 6 months post-surgery ]
|Study Start Date:||November 1999|
|Study Completion Date:||January 2009|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
Experimental: FDG-PET scan +/- neoadjuvant chemotherapy + surgery
Patients receive fludeoxyglucose F 18 (FDG) IV followed 45-60 minutes later by positron emission tomography (PET) imaging. Confirmatory studies, such as biopsy or other imaging studies, are then conducted to confirm the FDG PET imaging results. Patients with no metastases identified by FDG PET imaging may undergo esophagectomy with or without neoadjuvant chemoradiotherapy within 1 month of evaluation.
Patients are followed within 6 months after surgery.
|Procedure: conventional surgery Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18 Drug: chemotherapy Radiation: Radiotherapy|
To evaluate whether FDG-PET imaging can detect lesions that would preclude surgery (esophagectomy) in patients found to be surgical candidates by standard imaging procedures.
To use the collected data to generate hypotheses to be used in future studies, such as which types of previously undetected lesions FDG-PET imaging is best able to identify.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004867
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|Study Chair:||Bryan F. Meyers, MD, MPH||Washington University Siteman Cancer Center|