Positron Emission Tomography in Determining Stage of Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT00004867|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Procedure: conventional surgery Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18 Drug: chemotherapy Radiation: Radiotherapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||235 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Carcinoma of the Thoracic Esophagus|
|Study Start Date :||November 1999|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||January 2009|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004867
|Study Chair:||Bryan F. Meyers, MD, MPH||Washington University Siteman Cancer Center|