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
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.
Studieöversikt
Status
Intervention / Behandling
- Genetisk: analys av genuttryck
- Genetisk: analys av proteinuttryck
- Procedur: terapeutisk konventionell kirurgi
- Övrig: immunoenzymteknik
- Genetisk: DNA-metyleringsanalys
- Procedur: biopsi
- Genetisk: omvänd transkriptas-polymeraskedjereaktion
- Övrig: diagnostisk laboratoriebiomarköranalys
- Strålning: fludeoxiglukos F 18
- Övrig: immunhistokemi färgningsmetod
- Genetisk: polymeraskedjereaktion
- Genetisk: fluorescens in situ hybridisering
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10065
- Memorial Sloan-Kettering Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Feasibility of ex-vivo imaging of colon cancer and colon polyps using fludeoxyglucose F 18 positron emission tomography (FDG PET)
Tidsram: 2 years
|
2 years
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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)
Tidsram: 2 years
|
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)
Tidsram: 2 years
|
2 years
|
|
Differences in molecular and genetic profiles between normal colonic mucosa, polyps, and cancer
Tidsram: 2 years
|
2 years
|
|
Differences and similarities in molecular and genetic profiles between FDG-positive cancers and polyps
Tidsram: 2 years
|
2 years
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Marc J. Gollub, MD, Memorial Sloan Kettering Cancer Center
- Huvudutredare: Suresh Jhanwar, PhD, Memorial Sloan Kettering Cancer Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 07-114
- P30CA008748 (U.S.S. NIH-anslag/kontrakt)
- MSKCC-07114
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