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2 Phase Comparison of Pre-operative CT and PET Images for Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01821105
Recruitment Status : Completed
First Posted : March 29, 2013
Results First Posted : February 3, 2016
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Edward Martin, Ohio State University Comprehensive Cancer Center

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
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 Procedure: PET Scan Procedure: CT Scan Radiation: fludeoxyglucose F 18 Procedure: computer-aided detection/diagnosis Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

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 datasets.

OUTLINE:

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 system.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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.
Study Start Date : March 2004
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Preoperative PET and CT Scans
Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.
 Procedure: PET Scan
All patients will receive whole body PET scans (chest-abdomen-pelvis).

Procedure: CT Scan
All patients will receive CT scans of the abdomen and pelvis with contrast.

Radiation: fludeoxyglucose F 18
Given IV
Other Names:
  • 18FDG
  • FDG

Procedure: computer-aided detection/diagnosis
Undergo computer-aided detection/diagnosis during surgery


Outcome Measures
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Primary Outcome Measures :
  1. Detection of Position Accuracy With Handheld Probe on Anatomical Location. [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. All Adverse Events and Complications [ Time Frame: up to 12 months ]
  2. Tumor Detection [ Time Frame: At surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821105


Locations
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United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Edward Martin, MD Ohio State University
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Edward Martin, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01821105    
Other Study ID Numbers: OSU-0375
NCI-2012-01242 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 29, 2013    Key Record Dates
Results First Posted: February 3, 2016
Last Update Posted: March 2, 2016
Last Verified: February 2016
Keywords provided by Edward Martin, Ohio State University Comprehensive Cancer Center:
computed tomography
CT scan
positron emission tomography
PET
Metastatic Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action