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NCT00226304 · ClinicalTrials.gov registry record
Evaluation of Brain Lesions in HIV-infected Patients for Diagnosis of Primary Central Nervous System Lymphoma
A clinical trial of HIV Infections and Lymphoma, AIDS-Related, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 120
- Enrollment target
- 1
- Study location
NCT00226304: Completed study of HIV Infections and Lymphoma, AIDS-Related, sponsored by National Institutes of Health Clinical Center (CC).
NCT00226304 is a study of HIV Infections and Lymphoma, AIDS-Related that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 120 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00226304, a study of HIV Infections and Lymphoma, AIDS-Related, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the usefulness of two tests in quickly distinguishing whether a patient with HIV infection and focal brain lesions (an injury in a specific area of the brain) has a rare type of cancer called primary central nervous system lymphoma (PCNSL), or a parasitic infection called toxoplasmic encephalitis. Toxoplasmic encephalitis is caused by a parasite and can be treated with antibiotics. PCNSL (lymphoma of the brain or spinal cord) must be definitively diagnosed with a brain biopsy (removal of a small piece of brain tissue), and the treatment is radiation therapy and chemotherapy. The tests under study for diagnosing PCNSL or toxoplasmic encephalitis are measurement of Epstein Barr virus (EBV) DNA in cerebrospinal fluid (CSF) and FDG-PET scan of the brain. EBV is often found in the CSF of people with PCNSL. The study also will compare the accuracy of two imaging techniques-TI-SPECT and FDG-PET-in distinguishing between toxoplasmosis and PCNSL. Patients 18 years of age and older who have HIV infection and at least one focal brain lesion without a prior history of PCNSL or toxoplasmic encephalitis may be eligible for this study. Each candidate is screened with a medical history, physical examination, blood and urine tests and MRI scans of the brain. Upon entering the study, all participants take medication to treat toxoplasmic encephalitis. They undergo lumbar puncture (spinal tap) to obtain CSF for analysis, an FDG-PET scan, and a 201TI-SPECT scan. For the PET scan, a radioactive substance is injected into an arm, followed by scanning in a doughnut-shaped machine similar to a CT scanner. SPECT is similar to PET but uses a different radioactive tracer, and the patient lies on a table while the SPECT camera rotates around the patient's head. Patients whose test results indicate a low risk for lymphoma continue antibiotic therapy for toxoplasmosis. They have repeat MRI scans around 4, 7, and 14 days after starting the drug to monitor the response
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2005-09-20 |
| Est. Completion | 2009-04-15 |
What the finished NCT00226304 record still lists
NCT00226304 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 0 interventions.
NCT00226304 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00226304 about?
NCT00226304 is a clinical study titled "Evaluation of Brain Lesions in HIV-infected Patients for Diagnosis of Primary Central Nervous System Lymphoma". This study will evaluate the usefulness of two tests in quickly distinguishing whether a patient with HIV infection and focal brain lesions (an injury in a specific area of the brain) has a rare type of cancer called primary central nervous system lymphoma (PCNSL), or a parasitic infection called to...
What is the current status of trial NCT00226304?
This trial is currently completed. The enrollment target is 120 participants. The study started on 2005-09-20. Estimated completion is 2009-04-15.
What conditions does trial NCT00226304 study?
This clinical trial studies the following conditions: HIV Infections, Lymphoma, AIDS-Related.
Who is sponsoring clinical trial NCT00226304?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00226304 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00226304's enrollment target sits among peer trials
120 239th of 542 higher than 295 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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