Fludeoxyglucose F 18 PET Imaging in Determining Protein and Gene Expression Signatures in Patients With Premalignant Polyps or Colon Cancer
NCT ID: NCT00550628
Last Updated: 2015-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
8 participants
OBSERVATIONAL
2007-09-30
2011-09-30
Brief Summary
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PURPOSE: This clinical trial is studying fludeoxyglucose F 18-PET imaging to see how well it works in determining protein and gene expression signatures in patients with premalignant polyps or colon cancer.
Detailed Description
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Primary
* To determine the feasibility of ex-vivo imaging of colon cancer and colon polyps using fludeoxyglucose F 18 positron emission tomography (FDG PET).
* To evaluate the differences in molecular and genetic profiles between FDG-positive polyps and FDG-negative polyps to suggest what gene mutations and abnormal mRNA and/or protein expressions may be required for FDG avidity ("signature" for FDG avidity).
Secondary
* To evaluate the differences in molecular and genetic profiles between FDG-positive polyps and FDG-positive cancers to suggest what gene mutations and abnormal mRNA and/or protein expressions may be required for cancer formation ("signature" for cancer).
* To evaluate the differences in molecular and genetic profiles between normal colonic mucosa, polyps, and cancer.
* To evaluate the differences and similarities in molecular and genetic profiles between FDG-positive cancers and polyps.
OUTLINE: Part I: Patients receive fludeoxyglucose F 18 (FDG) IV followed 45-60 minutes later by surgery to remove part or all of the colon. Tissue samples of the colon undergo positron emission tomography (PET) imaging.
Part II: Tissue samples are analyzed for glucose transporters proteins (Glut-1, 2, 3, 4, 5, 7) via IHC; presence of K-ras mutation (invariable mutant site on codon 12, 13) via PCR; 18q deletion via fluorescence in situ hybridization (FISH) or DCC IHC; MCT-1, Hex-1, Hex-2, and COX-2 expression levels via quantitative RT-PCR method or western blot; APC mutation via PCR- In Vitro Synthesized-Protein Assay or RT-PCR direct sequencing method; p53 mutation detection via immunochemistry, RT-PCR direct sequence methods, and western blot; methylation alteration of MGMT, CDKN2A, HLTF, MLH1, TIMP3, HIF1, BNIP3, and HRK via methylation detecting microchip; and specific gene methylations via methylation-specific PCR. Some tissue samples may be saved and banked for future studies.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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resection of a non-sarcomatous primary colon neoplasm
The surgically removed colon will undergo ex-vivo imaging after examination in pathology. A PET scanner will be used to acquire a scan of the whole specimen.
DNA methylation analysis
fluorescence in situ hybridization
gene expression analysis
polymerase chain reaction
protein expression analysis
reverse transcriptase-polymerase chain reaction
diagnostic laboratory biomarker analysis
immunoenzyme technique
immunohistochemistry staining method
biopsy
therapeutic conventional surgery
fludeoxyglucose F 18
Interventions
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DNA methylation analysis
fluorescence in situ hybridization
gene expression analysis
polymerase chain reaction
protein expression analysis
reverse transcriptase-polymerase chain reaction
diagnostic laboratory biomarker analysis
immunoenzyme technique
immunohistochemistry staining method
biopsy
therapeutic conventional surgery
fludeoxyglucose F 18
Eligibility Criteria
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Inclusion Criteria
* Age 15 to 100
* Undergoing resection of a non-sarcomatous primary colon neoplasm who also has 2 or more adenomas each greater than or equal to 7-10mm in size which are anticipated to be removed with the colon specimen.
* It will be known from MSKCC or outside studies (barium enema, endoscopy, PET/CT, or CT colonography) that the patient has at least 2 proven adenomas 7-10 mm or greater and a primary colon neoplasm
Exclusion Criteria
15 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Marc J. Gollub, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Suresh Jhanwar, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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MSKCC-07114
Identifier Type: -
Identifier Source: secondary_id
07-114
Identifier Type: -
Identifier Source: org_study_id