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

Comparing Single Photon Emission Computed Tomography (SPECT) and Liver Biopsy to Evaluate the Liver in Patients With HIV and Hepatitis C Virus

29. juli 2008 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

Use of Single Photon Emission Computed Tomography (SPECT) as a Noninvasive Alternative to Liver Biopsies in Assessing Liver Involvement in Subjects Coinfected With HIV and Hepatitis C Virus (HCV)

The purpose of this study is to find if the Single Photon Emission Computed Tomography (SPECT) scan is as effective as a liver biopsy (using a special needle to remove tissue from the liver) in examining liver damage in patients with HIV and hepatitis C virus (HCV).

A standard way to examine the liver for disease has been to perform a liver biopsy. The SPECT scan, which takes a picture of the liver, has been found to be effective in determining liver damage but studies need to be done in patients with hepatitis. This study will compare the effectiveness of the liver biopsy and SPECT scan in determining liver disease in patients with HIV and HCV. The SPECT scan might be a good replacement for the liver biopsy if it is found to be as good as or better than liver biopsies.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Assessment with a liver biopsy is currently the standard of practice to determine the status of liver involvement in patients with HCV. A direct comparison between SPECT results and liver pathology has been examined in patients with liver disease other than infectious hepatitis. SPECT has been found to be more accurate than standard liver-spleen scans in assessing liver pathology. While current data suggest that liver pathology may correlate with SPECT, which specific SPECT parameters are predictive of certain hepatic pathology is unknown. The pilot study will compare SPECT parameters with the results of liver biopsies to determine the limitations of SPECT.

All screened patients are registered into Step 1, in which they receive a radioactive tracer injection and SPECT scan. Specific SPECT parameters will be measured to determine a grading scale corresponding to that used in liver biopsy results. Some patients undergoing a second liver biopsy in A5071 are enrolled into Step 2, with permission from protocol co-chairs, in which a pregnancy test and second SPECT scan are performed. Patients are reimbursed for completing each SPECT scan. SPECT scans or copies are reviewed to establish which parameters correspond to category E of the Knodell stage based on severity of fibrosis.

Undersøgelsestype

Observationel

Tilmelding

44

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Stanford, California, Forenede Stater, 943055107
        • Stanford Univ Med Ctr
    • Florida
      • Miami, Florida, Forenede Stater, 331361013
        • Univ of Miami School of Medicine
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96816
        • Univ of Hawaii
    • New York
      • New York, New York, Forenede Stater, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • Rochester, New York, Forenede Stater, 14642
        • Univ of Rochester Medical Center
      • Rochester, New York, Forenede Stater, 14642
        • Community Health Network Inc
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 275997215
        • Univ of North Carolina
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 452670405
        • Univ of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Univ of Pennsylvania
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • Univ of Texas, Southwestern Med Ctr of Dallas
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Univ of Washington

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are enrolled in, or will soon enroll in, A5071. Patients may be eligible for the study if they are screening for A5071 and have a liver biopsy and SPECT scan but do not enter A5071. Patients who have stopped taking A5071 study drugs may also be eligible.
  • Have had a liver biopsy, or will soon have a liver biopsy.
  • Have a SPECT scan either before the liver biopsy or 2 weeks to 8 weeks after a liver biopsy.
  • Intend to have the SPECT scan within 7 days of study entry.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Are allergic to chemicals in the radioactive tracer used for the SPECT scan.
  • Are pregnant or breast-feeding.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Samarbejdspartnere og efterforskere

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Efterforskere

  • Studiestol: Bruce Shiramizu
  • Studiestol: Dickens Theodore

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.

Datoer for studieregistrering

Først indsendt

6. december 2000

Først indsendt, der opfyldte QC-kriterier

30. august 2001

Først opslået (Skøn)

31. august 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. juli 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juli 2008

Sidst verificeret

1. juni 2003

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACTG A5096
  • AACTG A5096

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 HIV-infektioner

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in South Korea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner