NCT00550628

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Colorectal Cancer
• Neoplasm of Uncertain Malignant Potential

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2007-10-30
• Last updated: 2015-12-23

Locations

1 site across 1 country: United States