- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01821105
2 Phase Comparison of Pre-operative CT and PET Images for Metastatic Colorectal Cancer
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 Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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
Other Names:
Undergo computer-aided detection/diagnosis during surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Detection of Position Accuracy With Handheld Probe on Anatomical Location.
Time Frame: up to 12 months
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up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All Adverse Events and Complications
Time Frame: up to 12 months
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up to 12 months
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Tumor Detection
Time Frame: At surgery
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At surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Edward Martin, MD, Ohio State University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Disease Attributes
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Recurrence
- Rectal Neoplasms
- Colonic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
Other Study ID Numbers
- OSU-0375
- NCI-2012-01242 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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