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Confocal Probe-based Endoscopic Imaging, Colorectal Cancer, Gastrointestinal (GI) Pathologies (ASGE-FNDT-1)

21. juni 2012 opdateret af: Michael Wallace, Mayo Clinic

The Role of Endoscopic Confocal Microscopy in Diagnosing Colorectal Cancer and Other Gastrointestinal Pathologies in Vivo

The recently developed endoscopic Confocal probe microscopy system allows imaging of surface epithelium during ongoing endoscopy (upper and lower) with the potential of immediate diagnosis of various GI pre-malignant and malignant lesions. The purpose of this study is to determine if using this new Confocal probe system can find pre-cancerous abnormalities in the stomach and colon.

Hypothesis: The confocal endomicroscopy images of colorectal lesions during the standard colonoscopies could help the classification in vivo of colorectal neoplastic and non-neoplastic lesions. This could direct further endoscopic interventions such as targeted biopsies of early colorectal cancer lesions and the endoscopic resection of such lesions during screening colonoscopies.

Primary Aim

  1. To determine the key confocal image features of neoplastic and pre-neoplastic colorectal lesions including flat and raised adenomatous polyps, intraepithelial neoplasia and cancer as well as benign lesions such as hyperplastic polyps and normal colonic epithelium and to estimate which morphologic features best distinguish neoplastic and non-neoplastic tissues.

    Secondary Aims:

  2. To determine the initial sensitivity and specificity of confocal microendoscopy imaging for classification of adenomatous from hyperplastic polyps of the colon.

  3. In this exploratory phase of the study to develop a library of confocal microendoscopic imaging characteristics of other GI pathologies such as:

    1. Barrett's esophagus in comparison to Barrett's esophagus with dysplasia, and normal squamous esophagus.
    2. Other encountered inflammatory and neoplastic conditions within the GI tract in which biopsy or removal of tissue would routinely be indicated.

The second phase of the study will focus on establishing the sensitivities, specificities, accuracy of confocal images of colorectal lesions and other GI pathologies as well as inter-observer agreement and learning curve in interpretation of confocal images.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Colorectal cancer is the second most common cause of cancer-related death in the U.S. Although removal of pre-malignant polyps has been shown to reduce the risk of colorectal cancer, up to 50% of removed colonic polyps are hyperplastic with no malignant potential. Removal of these benign polyps exposes the patient to polypectomy-related complications and cost without any benefit. Current standard endoscopes with the use of accessory confocal endomicroscopy probe will allow both routine and confocal microscopy imaging. Colonoscopies or upper endoscopies will be performed as routine including conscious sedation. A special fiber through the scope, combined with a small amount of dye called fluorescein given by vein, will be used to obtain microscopic views during the endoscopic procedure. If a colorectal lesion or other GI lesion is found that would normally require biopsy, the site of biopsy will be evaluated by confocal imaging with the Cellvizio-GI Fiberoptic probes prior to biopsy or removal of the suspicious tissue. Following image acquisition, the lesion will be biopsied or removed as per standard clinical care. Standard endoscopic variables for each lesion will be recorded including: name and record number, date, time, an exact time of fluorescein injection and time of image acquisition, lesion location, size, and suspected findings (inflammation, dysplasia, type of polyp) and final histological diagnosis.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

225

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Mayo Clinic

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

All patients presenting to Mayo Clinic, Jacksonville, Florida for a screening, surveillance colonoscopy, and/or a diagnostic and surveillance upper endoscopy, will be eligible based on inclusion and exclusion criteria. Eligible patients will be offered entry into the study on the day of the procedure in the hospital GI or Mayo Clinic Jacksonville endoscopy suites.

Beskrivelse

Inclusion Criteria:

  1. Ages 18 to 100
  2. Any patient undergoing screening and/or surveillance colonoscopy and/or upper endoscopy with possible biopsy or removal of tissue by polypectomy

Exclusion Criteria:

  1. Unwilling to consent
  2. Allergy to fluorescein
  3. Lack of any pathological state that would require biopsy at the time of endoscopy (will be considered "screen failure" since this will not be known until after consent is obtained and sedated endoscopy performed)
  4. Women of child-bearing age who are sexually active and not practicing an acceptable form of contraception

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Tværsnit

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Endoscopic Confocal microscopy may help distinguish small adenomatous polyps with malignant potential from non-neoplastic (hyperplastic) polyps in real- time enabling immediate diagnosis and removal of only polyps with truly malignant potential.
Tidsramme: one year
one year

Sekundære resultatmål

Resultatmål
Tidsramme
Endoscopic Confocal microscopy has the potential to fundamentally change the way endoscopy and pathology interact by allowing near histological-quality imaging in vivo, without the need, risk, and cost of tissue removal.
Tidsramme: one year
one year

Samarbejdspartnere og efterforskere

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

Sponsor

Mayo Clinic

Samarbejdspartnere

American Society for Gastrointestinal Endoscopy

Efterforskere

  • Ledende efterforsker: Michael B Wallace, M.D., Mayo Clinic

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. marts 2008

Primær færdiggørelse (Faktiske)

1. december 2010

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

31. marts 2009

Først indsendt, der opfyldte QC-kriterier

1. april 2009

Først opslået (Skøn)

2. april 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. juni 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juni 2012

Sidst verificeret

1. juni 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 07-007521
  • ASGE Grant#FNDT-1

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 .

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