Clinical trial NCT00006643: Comparing Single Photon Emission Computed Tomography (SPECT) and Liver Biopsy to Evaluate the Liver in Patients With HIV and Hepatitis C Virus
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Hepatitis C
Keywords: Liver
Hepatitis C
Biopsy
Tomography, Emission-Computed, Single-Photon
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Univ Med Ctr
state: California
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Honolulu
country: United States
facility: Univ of Hawaii
state: Hawaii
city: New York
country: United States
facility: Bellevue Hosp / New York Univ Med Ctr
state: New York
city: Rochester
country: United States
facility: Community Health Network Inc
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: Univ of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Univ of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: Univ of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Univ of Texas, Southwestern Med Ctr of Dallas
state: Texas
city: Seattle
country: United States
facility: Univ of Washington
state: Washington
Study officials:
name: Bruce Shiramizu
role: STUDY_CHAIR
name: Dickens Theodore
role: STUDY_CHAIR
References: