Positron Emission Tomography in Determining Stage of Esophageal Cancer
Esophageal Cancer
About this trial
This is an interventional diagnostic trial for Esophageal Cancer focused on measuring stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus
Eligibility Criteria
Inclusion Criteria: Patient must be ≥ 18 years of age. Patient must have histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (greater than or equal to 20 cm from incisors) or gastroesophageal junction. (Pathology report must be submitted). Patient must be deemed medically fit for surgical staging procedures and esophagectomy following the thoracic surgeon's evaluation of general medical fitness. Patient's clinical staging data (clinical examination, laboratory tests, and standard radiological staging assessments) must be obtained within 60 days prior to registration and must suggest that the tumor is potentially resectable, including tumors staged T1-3, N0-1, M0. Patient must be able to tolerate FDG-PET scan (e.g., not claustrophobic and able to lie supine for 1.5 hrs). Female patient of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to FDG-PET. NOTE: Pregnancy test is required to avoid unnecessary fetal radiation exposure and because the use of furosemide is contraindicated in pregnancy. Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study related procedures. Patient must provide written authorization to allow the use and disclosure of their protected health information. NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study pre-registration. A cancer survivor is eligible provided that ALL of the following criteria are met and documented: the patient has undergone potentially curative therapy for all prior malignancies and there has been no evidence of any prior malignancies for at least five years (except for completely resected cervical or non-melanoma skin cancer) and the patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies. Exclusion Criteria: Patient has proximal esophageal cancer (less than 20 cm from incisors) potentially requiring pharyngolaryngoesophagectomy. Patient has unresectable lesions (stage M1b, with biopsy confirmation of distant metastatic disease; or those with unresectable locoregional invasion, T4 Nx Mx). Patient has evidence of metastatic disease. NOTE: Obvious metastasis that is based on clinical evaluation includes any or all of the following: positive cytology of pleura, pericardium, or peritoneum; metastasis to brain, bone, lung, liver, or adrenals; positive biopsy or cytology of metastasis to supraclavicular lymph nodes; and involvement of the tracheobronchial tree (positive bronchoscopic biopsy or overt esophago-respiratory fistula). Patient has had a prior FDG-PET scan for evaluation of their esophageal cancer. Patient has uncontrolled diabetes mellitus, as evidenced by a fasting blood glucose value >200 mg/dL, within 12 hours of FDG-PET scan. Patient has received neoadjuvant chemotherapy and/or radiotherapy PRIOR to FDG-PET scan being performed.
Sites / Locations
- Comprehensive Cancer Center at University of Alabama at Birmingham
- Mobile Infirmary Medical Center
- University of South Alabama Cancer Research Institute
- Jonsson Comprehensive Cancer Center at UCLA
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- UCSF Comprehensive Cancer Center
- Stanford Cancer Center at Stanford University Medical Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Morton Plant Hospital
- Indiana University Cancer Center
- Greenebaum Cancer Center at University of Maryland Medical Center
- Cancer Center at Greater Baltimore Medical Center
- Massachusetts General Hospital Cancer Center
- William Beaumont Hospital - Royal Oak
- Siteman Cancer Center at Barnes-Jewish Hospital
- Memorial Sloan-Kettering Cancer Center
- SUNY Upstate Medical University Hospital
- Duke Comprehensive Cancer Center
- McDowell Cancer Center at Akron General Medical Center
- Bethesda North Hospital
- Tri-Health Good Samaritan Hospital
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
- Providence Cancer Center at Providence Portland Medical Center
- Westmoreland Regional Hospital
- Allegheny General Hospital
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- St. Clair Memorial Hospital
- Hollings Cancer Center at Medical University of South Carolina
- University of Tennessee, Memphis
- Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
- Baylor University Medical Center
- LDS Hospital
- Massey Cancer Center at Virginia Commonwealth University
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Arms of the Study
Arm 1
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.