Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

22. december 2015 opdateret af: Memorial Sloan Kettering Cancer Center

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

8

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan-Kettering Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

15 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

MSK clinic

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.
Genetisk: genekspressionsanalyse
Genetisk: proteinekspressionsanalyse
Procedure: terapeutisk konventionel kirurgi
Andet: immunoenzym teknik
Genetisk: DNA-methyleringsanalyse
Procedure: biopsi
Genetisk: omvendt transkriptase-polymerase kædereaktion
Andet: diagnostisk laboratoriebiomarkøranalyse
Stråling: fludeoxyglucose F 18
Andet: immunhistokemi farvningsmetode
Genetisk: polymerase kædereaktion
Genetisk: fluorescens in situ hybridisering

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
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)
Tidsramme: 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)
Tidsramme: 2 years
2 years
Differences in molecular and genetic profiles between normal colonic mucosa, polyps, and cancer
Tidsramme: 2 years
2 years
Differences and similarities in molecular and genetic profiles between FDG-positive cancers and polyps
Tidsramme: 2 years
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Memorial Sloan Kettering Cancer Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Marc J. Gollub, MD, Memorial Sloan Kettering Cancer Center
  • Ledende efterforsker: Suresh Jhanwar, PhD, Memorial Sloan Kettering Cancer Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2007

Primær færdiggørelse (Faktiske)

1. september 2011

Studieafslutning (Faktiske)

1. september 2011

Datoer for studieregistrering

Først indsendt

25. oktober 2007

Først indsendt, der opfyldte QC-kriterier

25. oktober 2007

Først opslået (Skøn)

30. oktober 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 07-114
  • P30CA008748 (U.S. NIH-bevilling/kontrakt)
  • MSKCC-07114

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kolorektal cancer

Kliniske forsøg med genekspressionsanalyse

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United States

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner