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

Completed

• Conditions: HIV Infections; Hepatitis C

• Registration Number: NCT00006643
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Timeline

• Study First Submitted: 2000-12-06
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2003-06
• Last Update Submitted: 2008-07-29
• Last Update Posted: 2008-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (11)

Univ of Miami School of Medicine; 🇺🇸 Miami, Florida, United States

Univ of Hawaii; 🇺🇸 Honolulu, Hawaii, United States

Bellevue Hosp / New York Univ Med Ctr; 🇺🇸 New York, New York, United States

Stanford Univ Med Ctr; 🇺🇸 Stanford, California, United States

Univ of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Univ of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Univ of Texas, Southwestern Med Ctr of Dallas; 🇺🇸 Dallas, Texas, United States

Univ of Washington; 🇺🇸 Seattle, Washington, United States

Univ of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Univ of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Community Health Network Inc; 🇺🇸 Rochester, New York, United States