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



Status:Completed
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:15 - Any
Updated:4/21/2016
Start Date:September 2007
End Date:September 2011

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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

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.

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 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).
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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