- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01439633
Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus
Pilot Study to Evaluate OFDI Surveillance and Image Guided Biopsy of the Esophagus
Studieoversigt
Detaljeret beskrivelse
Twenty four consenting patients undergoing esophagogastroduodenoscopy (EGD) surveillance following a confirmed diagnosis of Barrett's esophagus will be recruited at Massachusetts General Hospital (MGH) . Along with Optical Frequency Domain Imaging (OFDI) imaging and cautery marking for targeted biopsy, the patients will undergo a standard of care clinical Esophagogastroduodenoscopy (EGD) procedure including endoscopic random biopsy. This study requires the use of a balloon catheter which is a commonly used technique and is accepted in clinical practice for dilation of esophageal and colonic strictures and for photodynamic therapy.
Once in position, the OFDI tissue marking laser will be activated by the physician. The physician will control the marking and make two marks of a duration of 2 seconds each. The 2 seconds time period will limit the tissue effects to only the superficial layers of the esophageal mucosa.
It is expected that the total experimental time including insertion and inflation of the OFDI balloon catheter, OFDI imaging, tissue marking, and removal of the OFDI balloon will add approximately 15 minutes to the total length of the EGD.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients undergoing an EGD for Barrett's esophagus surveillance with a prior confirmed Barrett's segment at least 1 cm in length
- Patients must be over the age of 18
- Patient must be able to give informed consent
- Women with child bearing potential must have a negative pregnancy test prior to procedure
Exclusion Criteria:
- Patients on anti-platelet and anti-coagulation medications and NSAIDS at the time of procedure
- Patients with a history of hemostasis disorders
- Patients that are pregnant
- Patients with esophageal strictures
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: MGH OFDI marking and imaging
OFDI imaging
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Imaging of esophagus with OFDI system
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies.
Tidsramme: day 1, during diagnostic procedure
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Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue.
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day 1, during diagnostic procedure
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Guillermo Tearney, MD PhD, Massachusetts General hospital
- Ledende efterforsker: Norman Nishioka, MD, Massachusetts General hospital
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2010-P-000553
- 2R01CA103769-06A1 (U.S. NIH-bevilling/kontrakt)
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Kliniske forsøg med Barretts spiserør
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NinePoint MedicalAfsluttetIntramucosal Adenocarcinom | Barrett's-associeret dysplasiHolland
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Erbe Elektromedizin GmbHNAMSA; Kansas City Veteran Affairs Medical Center; Erbe USA IncorporatedAfsluttetBarretts spiserør | Højgradig dysplasi i Barrett-esophagus | Lavgradig dysplasi i Barrett-esophagusForenede Stater
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Maria Sklodowska-Curie National Research Institute...Centre of Postgraduate Medical EducationAfsluttetBarretts esophagus med lavgradig dysplasi
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Tomasz RomańczykAfsluttetHeterotopisk maveslimhinde i den proksimale esophagusPolen
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University Medical Center GroningenAfsluttetSpiserørskræft | Barrett Esophagus | Dysplasi i Barrett EsophagusHolland
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Johns Hopkins UniversityAmerican Society for Gastrointestinal Endoscopy; Pentax Medical CorporationAfsluttetBarretts esophagus, esophageal intraepithelial neoplasiForenede Stater, Tyskland
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Coordinación de Investigación en Salud, MexicoRekrutteringIntestinal Metaplasi | Dysplasi | Barretts esophagus med lavgradig dysplasiMexico
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International Agency for Research on CancerUniversity of Cambridge; Kilimanjaro Clinical Research InstituteAfsluttet
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Nantes University HospitalRekruttering
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Columbia UniversityNational Cancer Institute (NCI); University of MichiganRekruttering
Kliniske forsøg med MGH OFDI marking
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Massachusetts General HospitalAfsluttetGaldeforsnævringForenede Stater
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Massachusetts General HospitalAfsluttet
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Massachusetts General HospitalAfsluttet
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Massachusetts General HospitalNational Cancer Institute (NCI); National Institutes of Health (NIH)AfsluttetSund og rask | Barretts spiserør | MavesyretilbageløbForenede Stater
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Massachusetts General HospitalNational Heart, Lung, and Blood Institute (NHLBI)Tilmelding efter invitationKoronar arterioskleroseForenede Stater
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Massachusetts General HospitalAfsluttet
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Massachusetts General HospitalTilmelding efter invitationSund og rask | CøliakiForenede Stater
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Massachusetts General HospitalNational Cancer Institute (NCI); National Institutes of Health (NIH)Aktiv, ikke rekrutterendeBarretts spiserørForenede Stater
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Massachusetts General HospitalNational Cancer Institute (NCI); National Institutes of Health (NIH)AfsluttetAtrieflimrenForenede Stater
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Massachusetts General HospitalNational Cancer Institute (NCI); National Institutes of Health (NIH)AfsluttetEosinofil øsofagitis | Barretts spiserørForenede Stater