Comparing Single Photon Emission Computed Tomography (SPECT) and Liver Biopsy to Evaluate the Liver in Patients With HIV and Hepatitis C Virus
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
California
-
Stanford, California, Stany Zjednoczone, 943055107
- Stanford Univ Med Ctr
-
-
Florida
-
Miami, Florida, Stany Zjednoczone, 331361013
- Univ of Miami School of Medicine
-
-
Hawaii
-
Honolulu, Hawaii, Stany Zjednoczone, 96816
- Univ of Hawaii
-
-
New York
-
New York, New York, Stany Zjednoczone, 10016
- Bellevue Hosp / New York Univ Med Ctr
-
Rochester, New York, Stany Zjednoczone, 14642
- Univ of Rochester Medical Center
-
Rochester, New York, Stany Zjednoczone, 14642
- Community Health Network Inc
-
-
North Carolina
-
Chapel Hill, North Carolina, Stany Zjednoczone, 275997215
- Univ of North Carolina
-
-
Ohio
-
Cincinnati, Ohio, Stany Zjednoczone, 452670405
- Univ of Cincinnati
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Univ of Pennsylvania
-
-
Texas
-
Dallas, Texas, Stany Zjednoczone, 75390
- Univ of Texas, Southwestern Med Ctr of Dallas
-
-
Washington
-
Seattle, Washington, Stany Zjednoczone, 98104
- Univ of Washington
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Współpracownicy i badacze
Śledczy
- Krzesło do nauki: Bruce Shiramizu
- Krzesło do nauki: Dickens Theodore
Daty zapisu na studia
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby Układu Pokarmowego
- Zakażenia wirusem RNA
- Choroby wirusowe
- Infekcje
- Infekcje przenoszone przez krew
- Choroby zakaźne
- Choroby wątroby
- Infekcje Flaviviridae
- Zapalenie wątroby, wirusowe, ludzkie
- Infekcje enterowirusowe
- Infekcje Picornaviridae
- Zapalenie wątroby
- Wirusowe Zapalenie Wątroby typu A
- Wirusowe zapalenie wątroby typu C
Inne numery identyfikacyjne badania
- ACTG A5096
- AACTG A5096
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .