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

Last updated: December 22, 2015
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Completed

Phase

N/A

Condition

Colon Cancer; Rectal Cancer

Cancer

Colon Cancer

Treatment

N/A

Clinical Study ID

NCT00550628
07-114
MSKCC-07114
P30CA008748
  • Ages > 15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ormore adenomas each greater than or equal to 7-10mm in size which are anticipated to beremoved with the colon specimen.

  • It will be known from MSKCC or outside studies (barium enema, endoscopy, PET/CT, or CTcolonography) that the patient has at least 2 proven adenomas 7-10 mm or greater and aprimary colon neoplasm

Exclusion

Subject Exclusion Criteria:

  • Insulin-dependent diabetics (as established by routine history and presurgicallaboratory tests).

Study Design

Total Participants: 8
Study Start date:
September 01, 2007
Estimated Completion Date:
September 30, 2011

Study 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.

Connect with a study center

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

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