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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00550628
First received: October 25, 2007
Last updated: February 28, 2013
Last verified: February 2013
  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
Genetic: DNA methylation analysis
Genetic: fluorescence in situ hybridization
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Genetic: protein expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: diagnostic laboratory biomarker analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Procedure: biopsy
Procedure: therapeutic conventional surgery
Radiation: fludeoxyglucose F 18

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Feasibility of ex-vivo imaging of colon cancer and colon polyps using fludeoxyglucose F 18 positron emission tomography (FDG PET) [ Time Frame: 2 years ] [ 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) [ Time Frame: 2 years ] [ 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) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Differences in molecular and genetic profiles between normal colonic mucosa, polyps, and cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Differences and similarities in molecular and genetic profiles between FDG-positive cancers and polyps [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: September 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
resection of a non-sarcomatous primary colon neoplasm
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.
Genetic: DNA methylation analysis Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: protein expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: diagnostic laboratory biomarker analysis Other: immunoenzyme technique Other: immunohistochemistry staining method Procedure: biopsy Procedure: therapeutic conventional surgery Radiation: fludeoxyglucose F 18

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

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550628

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
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

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00550628     History of Changes
Other Study ID Numbers: 07-114, P30CA008748, MSKCC-07114
Study First Received: October 25, 2007
Last Updated: February 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
neoplasm of uncertain malignant potential
colon cancer

Additional relevant MeSH terms:
Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Precancerous Conditions
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014