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
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.
Subject
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Feasibility of ex-vivo imaging of colon cancer and colon polyps using fludeoxyglucose F 18 positron emission tomography (FDG PET)
2 years
No
Marc J. Gollub, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
07-114
NCT00550628
September 2007
September 2011
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |