A 2 Phase Comparison of Pre-operative CT AND PET Images in the Intraoperative Detection of Disease to a Hand-held Probe, and to an Intraoperative CT Scan in Patients Undergoing Surgery for Metastatic Colorectal Cancer.
- 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
- 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
- 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).