Positron Emission Tomography in Determining Stage of Esophageal Cancer

OBJECTIVES:

Primary Objective:

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.

Secondary Objective:

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.

Inclusion Criteria:

1. Patient must be ≥ 18 years of age.

2. 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).

3. Patient must be deemed medically fit for surgical staging procedures and
esophagectomy following the thoracic surgeon's evaluation of general medical fitness.

4. 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.

5. Patient must be able to tolerate FDG-PET scan (e.g., not claustrophobic and able to
lie supine for 1.5 hrs).

6. 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.

7. 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.

8. 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.

9. 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:

1. Patient has proximal esophageal cancer (less than 20 cm from incisors) potentially
requiring pharyngolaryngoesophagectomy.

2. Patient has unresectable lesions (stage M1b, with biopsy confirmation of distant
metastatic disease; or those with unresectable locoregional invasion, T4 Nx Mx).

3. 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).

4. Patient has had a prior FDG-PET scan for evaluation of their esophageal cancer.

5. Patient has uncontrolled diabetes mellitus, as evidenced by a fasting blood glucose
value >200 mg/dL, within 12 hours of FDG-PET scan.

6. Patient has received neoadjuvant chemotherapy and/or radiotherapy PRIOR to FDG-PET
scan being performed.