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

Non-Invasive Characterization in Cardiac Sarcoidosis

3. juli 2018 opdateret af: Venkatesh L. Murthy, M.D., Ph.D., University of Michigan
In a study of Cardiac sarcoidosis, a serious heart condition, a radiotracer is being used to examine inflammation.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Cardiac sarcoidosis is a serious medical condition which affects the heart. The purpose of this study is to characterize the relationship between the FDG PET findings and other markers of inflammation including using a new targeted PET radiotracer, 11C-PBR28, and analysis of blood specimens.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Hospital

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

Beskrivelse

Inclusion Criteria:

  1. 18 years of age or older
  2. must have undergone a cardiac positron emission tomography (PET) scan using 18F-fluorodeoxyglucose (FDG) for clinical reasons (i.e. referred by your doctor) within the preceding 30 days which showed evidence of active inflammation in your heart.

Exclusion Criteria:

  1. If you have two copies of a genetic variation called rs6971 which will prevent this tracer from generating high-quality images you may not participate. If you consent, a blood sample will be drawn to check whether you have this genetic variation.
  2. Pregnancy or breastfeeding. If you are female and still experience menstrual periods, you must be willing to use contraception until your participation in the study is complete.
  3. Allergy or intolerance to contrast dye containing gadolinium
  4. Claustrophobia which would prevent you from completing an approximately one hour MRI scan
  5. Inability to lie flat with your arms by your head
  6. Abnormal kidney function (estimated GFR(glomerular filtration rate) <60 ml/min/1.73 m2)
  7. Implanted pacemaker, defibrillator or other medical devices which are not safe for 3 Tesla MRI
  8. Metal in the eyes or shrapnel in the body

  9. If you are clinically unstable you may not participate in this study. For example, if you have potentially life threatening abnormal heart rhythms which are not controlled by medication or other treatments, you cannot participate. Also, if you need medications to increase your blood pressure or cardiac function due to weak heart muscle, you cannot participate.

    -

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 11C-PBR PET

Subjects will have a blood sample drawn to evaluate the presence of a specific genetic variation which would prevent the new type of imaging test we are evaluating from working and we will test the inflammatory cells in the blood for the same purpose.

All participants who proceed will have to return on at least one additional day to undergo a positron emission tomography (PET) scan similar to the scan your doctor ordered. we will use 11C-PBR28 as the radiotracer. This study will evaluate whether 11C-PBR28 can show areas of inflammation due to cardiac sarcoidosis. On either the same day or a different day, you will also undergo a cardiac MRI.
Enhed: 11C-PBR PET

Subjects will have a positron emission tomography (PET) CT scan using 11C-PBR28 as a radiotracer. This study will evaluate inflammation due to cardiac sarcoidosis. The CT scan will improve the images. The total scan time will be about 30 minutes. There will also be some time required for prep, such as inserting an intravenous (IV) catheter in an arm or forearm. Including prep time, the scan will take approximately two hours.

Subjects will also undergo a cardiac MRI. Cardiac MRI uses strong magnetic fields to make pictures of the heart. We will use gadolinium containing contrast material, given through an intravenous (IV) catheter to highlight areas of scar in your heart which may be due to cardiac sarcoidosis. This scan will take about 60 minutes.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ratio of 11C-PBR28 in the Myocardium
Tidsramme: 1 hour scan
The primary outcome of this study will be the ratio of 11C-PBR28 PET activity in myocardial regions with inflammation indicated by FDG PET and/or edema indicated by increased T2 signal with cardiac MRI compared to the 11C-PBR28 PET activity in myocardial segments which appear normal on FDG PET and cardiac MRI. The primary outcome is thus the intensity of uptake in abnormal regions as a percentage of the intensity of uptake in normal segments.
1 hour scan

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Ratio of 11C-PBR28 PET Activity in Cardiac Regions With Fibrosis
Tidsramme: 1 hour scan

As a secondary outcome of this study we will evaluate the ratio of 11C-PBR28 PET activity in regions with fibrosis indicated by decreased myocardial perfusion on 82Rb PET and/or late gadolinium enhancement on cardiac MRI without imaging signs of active inflammation compared to 11C-PBR28 PET activity in myocardial segments which appear normal on 82Rb PET, FDG PET and cardiac MRI. This outcome will thus be expressed by 11C-PBR28 PET uptake in fibrotic regions as a percentage of uptake in normal segments

We will also evaluate the concordance between extracardiac activity seen in 11C-PBR28 and FDG PET, and when available, histopathology of contemporaneous biopsy specimens.
1 hour scan

Samarbejdspartnere og efterforskere

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

Sponsor

University of Michigan

Efterforskere

  • Ledende efterforsker: Venkatesh L. Murthy, M.D., University of Michigan

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 (Faktiske)

4. april 2014

Primær færdiggørelse (Faktiske)

7. juli 2015

Studieafslutning (Faktiske)

7. juli 2015

Datoer for studieregistrering

Først indsendt

16. december 2013

Først indsendt, der opfyldte QC-kriterier

19. december 2013

Først opslået (Skøn)

20. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HUM00079881

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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 Hjerte sarkoidose

Kliniske forsøg med 11C-PBR PET

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Portugal

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner