2 Phase Comparison of Pre-operative CT and PET Images for Metastatic Colorectal Cancer
Condition: Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV A Bladder Cancer; Stage IV A Rectal Cancer; Stage IV B Colon Cancer; Stage IV B Rectal Cancer
MeSH terms: Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Recurrence
Intervention: PET Scan; CT Scan; fludeoxyglucose F 18; computer-aided detection/diagnosis
Intervention description: All patients will receive whole body PET scans (chest-abdomen-pelvis).; All patients will receive CT scans of the abdomen and pelvis with contrast.; Given IV; Undergo computer-aided detection/diagnosis during surgery
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: computed tomography; CT scan; positron emission tomography; PET; Metastatic Colorectal Cancer

Summary:

      This pilot phase II studies how well computed tomography (CT) and positron emission
      tomography (PET) imaging works in detecting disease in patients undergoing surgery for
      metastatic colorectal cancer. Diagnostic procedures, such as CT and PET scans, done before
      and during surgery may help find colorectal cancer and help guide surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically-confirmed colorectal carcinoma and preoperative PET scan
             with evidence of hypermetabolic lesions suspicious for cancer will be eligible for
             this study. In cases of primary cancer, there must be a tissue-confirmed diagnosis. In
             recurrent cases, patients must have clinical evidence by CT or MRI of disease suitable
             for resection.

          -  Patients must be candidates for clinically indicated surgery.

          -  Patients with recurrent disease may have had prior surgery and/or chemotherapy with no
             limit to the number of prior therapeutic procedures or chemotherapeutic regimens.

          -  Patients must have a performance status of 0, 1 or 2 by ECOG(Eastern Cooperative
             Oncology Group)standards.

          -  Patients must give written informed consent including consent to have IV line placed
             for FDG administration.

          -  Patients must be at least 18 years of age. Children under the age of 18 are excluded
             from the study due to the rarity of colorectal cancer in children.

          -  Because radiolabeled agents are known to be teratogenic, women of child-bearing
             potential and men must agree to use an acceptable form of contraception prior to study
             entry and for the duration of the study participation. Should a woman become pregnant
             or suspect she is pregnant while participating in this study, she should inform her
             treating physician immediately.

          -  Organ function requirements: Patients must have organ and marrow function adequate to
             undergo laparotomy. Specifically:

          -  Serum creatinine < 2.0 mg/dl

          -  Serum bilirubin < 2.0 mg/dl

          -  AST(aspartate aminotransferase,serum glutamate oxaloacetate transaminase, serum
             glutamate oxaloacetate transaminase,serum glutamate pyruvate
             transaminase)[SGOT]/ALT[SGPT]<4 times institutional upper limit of normal

          -  Total WBC(white blood cell)>4,000/mm3 or ANC(absolute neutrophil count)> 1,500/mm3

          -  Platelets > 100,000/mm3

          -  Hgb >10g/dl

          -  Patient must have no clinically significant cardiac disease (New York Heart
             Association Class III/IV); no serious infection requiring treatment with antibiotics;
             no other serious ill-ness or illness requiring the use of steroids; no clinically
             significant pulmonary disease or other illness that would contraindicate or increase
             the risk of complications at surgery.

          -  Fasting blood sugar less than 120 mg/dl

        Exclusion Criteria:

          -  Patients with active CNS (central nervous system)tumor involvement are ineligible.

          -  Any patient who has retained childbearing potential will not be pregnant or lactating
             and must use adequate contraception to assure avoidance of conception.

          -  Body size prohibits use of the diagnostic equipment (portable CT scanner).

          -  Tumor burden is so great (as determined by preoperative PET scanning or intraoperative
             findings) that further surgery is not advised.

          -  If lesions are detected with preoperative CT but not with PET scanning (in other
             words, all patients will have a positive PET scan as part of the inclusion criteria).