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.
Procedure: conventional surgery
Procedure: positron emission tomography
Procedure: radionuclide imaging
Radiation: fludeoxyglucose F 18
|Study Design:||Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
- The proportion of false positive lesions found by FDG-PET. [ Time Frame: Up to 6 months post-surgery ] [ Designated as safety issue: No ]
|Study Start Date:||November 1999|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (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
Show 35 Study Locations
|Study Chair:||Bryan F. Meyers, MD, MPH||Washington University Siteman Cancer Center|