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Fludeoxyglucose F 18 PET Imaging in Determining Protein and Gene Expression Signatures in Patients With Premalignant Polyps or Colon Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00550628
  Purpose

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.


Condition Intervention
Colorectal Cancer
Neoplasm of Uncertain Malignant Potential
Drug: fludeoxyglucose F 18
Procedure: DNA methylation analysis
Procedure: biopsy
Procedure: conventional surgery
Procedure: fluorescence in situ hybridization
Procedure: gene expression analysis
Procedure: immunoenzyme technique
Procedure: immunohistochemistry staining method
Procedure: laboratory biomarker analysis
Procedure: polymerase chain reaction
Procedure: protein expression analysis
Procedure: reverse transcriptase-polymerase chain reaction
Procedure: single photon emission computed tomography

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Fluorodeoxyglucose F18
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic
Official Title: 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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Feasibility of ex-vivo imaging of colon cancer and colon polyps using fludeoxyglucose F 18 positron emission tomography (FDG PET) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]
  • Differences in molecular and genetic profiles between normal colonic mucosa, polyps, and cancer [ Designated as safety issue: No ]
  • Differences and similarities in molecular and genetic profiles between FDG-positive cancers and polyps [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2007
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Undergoing resection of a nonsarcomatous primary colon neoplasm

    • Must have 2 or more adenomas each ≥ 7-10 mm in size which are anticipated to be removed with the colon specimen

PATIENT CHARACTERISTICS:

  • No insulin-dependent diabetics

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550628

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Marc J. Gollub, MD     212-639-2183        
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Marc J. Gollub, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Suresh Jhanwar, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000572373, MSKCC-07114
Study First Received: October 25, 2007
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00550628  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
neoplasm of uncertain malignant potential
colon cancer

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Polyps
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009