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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.

Phase 2
18 Years
Not Enrolling
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

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Trial Information

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.


I. To determine the feasibility of rigidly (linearly) registering PET to CT images and
applying this fused dataset to guide surgery with an image-guided navigation system and a
handheld positron probe in order to facilitate disease detection and improve resection
accuracy in advanced stage colorectal cancer.

II. To complete development of software for the nonlinear registration of PET and CT


Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis.
Patients then receive 18 F fludeoxyglucose (FDG) intravenously (IV) 60-90 minutes prior to
surgery and undergo intraoperative CT scans using a handheld probe and computer navigation

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).

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Position accuracy

Outcome Time Frame:

up to 12 months

Safety Issue:


Principal Investigator

Edward Martin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Institutional Review Board

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • 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
  • computed tomography
  • CT scan
  • positron emission tomography
  • PET
  • Metastatic Colorectal Cancer
  • Urinary Bladder Neoplasms
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms



Ohio State University Medical CenterColumbus, Ohio  43210