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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


N/A
15 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Neoplasm of Uncertain Malignant Potential

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Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Feasibility of ex-vivo imaging of colon cancer and colon polyps using fludeoxyglucose F 18 positron emission tomography (FDG PET)

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Marc J. Gollub, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07-114

NCT ID:

NCT00550628

Start Date:

September 2007

Completion Date:

September 2011

Related Keywords:

  • Colorectal Cancer
  • Neoplasm of Uncertain Malignant Potential
  • neoplasm of uncertain malignant potential
  • colon cancer
  • Neoplasms
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Precancerous Conditions

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021