Fludeoxyglucose F 18 PET Imaging in Determining Protein and Gene Expression Signatures in Patients With Premalignant Polyps or Colon Cancer

Study Overview
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Brief Summary
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RATIONALE: Diagnostic imaging procedures, such as fludeoxyglucose F 18 PET, may be effective in detecting cancer or recurrence of cancer, or premalignant polyps. 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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OBJECTIVES: 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.

Official Title
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Pilot Study of Ex-Vivo Molecular Polyp Imaging Using 18-F Fluorodeoxyglucose (FGD) Positron Emission Tomography (PET) in the Determination of Protein and Gene Expression Signatures of Premalignant Polyps

Conditions
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Colorectal Cancer, Neoplasm of Uncertain Malignant Potential

Intervention / Treatment
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* Genetic: DNA methylation analysis
* Genetic: fluorescence in situ hybridization
* Genetic: gene expression analysis
* Genetic: polymerase chain reaction
* Genetic: protein expression analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: diagnostic laboratory biomarker analysis
* Other: immunoenzyme technique
* Other: immunohistochemistry staining method
* Procedure: biopsy
* Procedure: therapeutic conventional surgery
* Radiation: fludeoxyglucose F 18


Participation Criteria
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Eligibility Criteria
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Subject Inclusion Criteria: Patients eligible for entry into the study are those: 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 Subject Exclusion Criteria: Insulin-dependent diabetics (as established by routine history and presurgical laboratory tests).

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| resection of a non-sarcomatous primary colon neoplasm<br>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. | Genetic: DNA methylation analysis<br> <br> Genetic: fluorescence in situ hybridization<br> <br> Genetic: gene expression analysis<br> <br> Genetic: polymerase chain reaction<br> <br> Genetic: protein expression analysis<br> <br> Genetic: reverse transcriptase-polymerase chain reaction<br> <br> Other: diagnostic laboratory biomarker analysis<br> <br> Other: immunoenzyme technique<br> <br> Other: immunohistochemistry staining method<br> <br> Procedure: biopsy<br> <br> Procedure: therapeutic conventional surgery<br> <br> Radiation: fludeoxyglucose F 18<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of ex-vivo imaging of colon cancer and colon polyps using fludeoxyglucose F 18 positron emission tomography (FDG PET) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 2 years | 
| 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) |  | 2 years | 
| Differences in molecular and genetic profiles between normal colonic mucosa, polyps, and cancer |  | 2 years | 
| Differences and similarities in molecular and genetic profiles between FDG-positive cancers and polyps |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoplasm of uncertain malignant potential, colon cancer