- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00874263
Confocal Probe-based Endoscopic Imaging, Colorectal Cancer, Gastrointestinal (GI) Pathologies (ASGE-FNDT-1)
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
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:
- To determine the initial sensitivity and specificity of confocal microendoscopy imaging for classification of adenomatous from hyperplastic polyps of the colon.
In this exploratory phase of the study to develop a library of confocal microendoscopic imaging characteristics of other GI pathologies such as:
- Barrett's esophagus in comparison to Barrett's esophagus with dysplasia, and normal squamous esophagus.
- 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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Florida
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Jacksonville, Florida, Forente stater, 32224
- Mayo Clinic
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Ages 18 to 100
- Any patient undergoing screening and/or surveillance colonoscopy and/or upper endoscopy with possible biopsy or removal of tissue by polypectomy
Exclusion Criteria:
- Unwilling to consent
- Allergy to fluorescein
- 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)
- Women of child-bearing age who are sexually active and not practicing an acceptable form of contraception
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Tverrsnitt
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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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
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one year
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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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
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one year
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michael B Wallace, M.D., Mayo Clinic
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Andre B, Vercauteren T, Buchner AM, Krishna M, Ayache N, Wallace MB. Software for automated classification of probe-based confocal laser endomicroscopy videos of colorectal polyps. World J Gastroenterol. 2012 Oct 21;18(39):5560-9. doi: 10.3748/wjg.v18.i39.5560.
- Shahid MW, Buchner A, Gomez V, Krishna M, Woodward TA, Raimondo M, Wallace MB. Diagnostic accuracy of probe-based confocal laser endomicroscopy and narrow band imaging in detection of dysplasia in duodenal polyps. J Clin Gastroenterol. 2012 May-Jun;46(5):382-9. doi: 10.1097/MCG.0b013e318247f375.
- Buchner AM, Shahid MW, Heckman MG, Krishna M, Ghabril M, Hasan M, Crook JE, Gomez V, Raimondo M, Woodward T, Wolfsen HC, Wallace MB. Comparison of probe-based confocal laser endomicroscopy with virtual chromoendoscopy for classification of colon polyps. Gastroenterology. 2010 Mar;138(3):834-42. doi: 10.1053/j.gastro.2009.10.053. Epub 2009 Nov 10.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 07-007521
- ASGE Grant#FNDT-1
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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