Ignite Creation Date:
2024-05-05 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006643
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
2000-12-06
Brief Title:
Comparing Single Photon Emission Computed Tomography SPECT and Liver Biopsy to Evaluate the Liver in Patients With HIV and Hepatitis C Virus
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2003-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AACTG A5096 | None | None | None |