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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00550628
Enrollment
8
Registered
2007-10-30
Start date
2007-09-30
Completion date
2011-09-30
Last updated
2015-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Neoplasm of Uncertain Malignant Potential

Keywords

neoplasm of uncertain malignant potential, colon cancer

Brief 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.

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.

Interventions

GENETICDNA methylation analysis
GENETICfluorescence in situ hybridization
GENETICgene expression analysis
GENETICpolymerase chain reaction
GENETICprotein expression analysis
GENETICreverse transcriptase-polymerase chain reaction
OTHERdiagnostic laboratory biomarker analysis
OTHERimmunoenzyme technique
OTHERimmunohistochemistry staining method
PROCEDUREbiopsy
PROCEDUREtherapeutic conventional surgery
RADIATIONfludeoxyglucose F 18

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion 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).

Design outcomes

Primary

MeasureTime frame
Feasibility of ex-vivo imaging of colon cancer and colon polyps using fludeoxyglucose F 18 positron emission tomography (FDG PET)2 years

Secondary

MeasureTime frame
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)2 years
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)2 years
Differences in molecular and genetic profiles between normal colonic mucosa, polyps, and cancer2 years
Differences and similarities in molecular and genetic profiles between FDG-positive cancers and polyps2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026