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

Memorial Sloan Kettering Cancer Center (MSK)

Status

Completed

Conditions

Neoplasm of Uncertain Malignant Potential

Colorectal Cancer

Treatments

Other: immunohistochemistry staining method

Genetic: polymerase chain reaction

Other: diagnostic laboratory biomarker analysis

Procedure: biopsy

Procedure: therapeutic conventional surgery

Genetic: fluorescence in situ hybridization

Genetic: DNA methylation analysis

Radiation: fludeoxyglucose F 18

Genetic: reverse transcriptase-polymerase chain reaction

Genetic: gene expression analysis

Genetic: protein expression analysis

Other: immunoenzyme technique

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT00550628

P30CA008748 (U.S. NIH Grant/Contract)

07-114

MSKCC-07114

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

8 participants in 1 patient group

resection of a non-sarcomatous primary colon neoplasm

Description:

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.

Treatment: