Status:
COMPLETED
Evaluation of Brain Lesions in HIV-infected Patients for Diagnosis of Primary Central Nervous System Lymphoma
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
HIV Infections
Lymphoma, AIDS-Related
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
Epstein Barr Virus (EBV)-associated primary central nervous system lymphoma (PCNSL) remains a major problem among AIDS patients. The clinical presentation is often clinically indistinguishable from to...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Adult (18 years old or older) HIV-infected patient
- HIV infected by OraQuick rapid test using saliva, venipuncture whole blood, or fingerstick whole blood; or by reactive ELISA and Western Blot as determined by an outside CLIA-approved laboratory facility or by NIH Clinical Pathology Laboratory or SAIC-Frederick Inc Monitoring Laboratory. HIV infection as determined by an outside CLIA-approved laboratory facility will be verified by a standard HIV-1 ELISA with Western Blot confirmation prior to brain biopsy.
- Evidence of contrast-enhancing focal brain lesion(s) as seen on MRI or CT
- Willingness to give informed consent and provided by Durable Power of Attorney. In the event that no Durable Power of Attorney has been designated and the patient is unable to do so, the NIH Ethics Committee will be consulted. All patients must designate a Durable Power of Attorney in order to participate in the study.
- Willingness to undergo the procedures involved in the diagnostic evaluation: lumbar puncture, FDG-PET scan, 201Tl-SPECT scan, and brain biopsy.
- Permit the storage of blood, CSF, and tissue samples for future research use
- Willingness to undergo HLA testing
- EXCLUSION CRITERIA:
- Previous PCNSL
- History of prior malignancy other than PCNSL unless in remission for 1 year or longer; non-melanoma skin cancer and Kaposi's sarcoma excepted
- History of previous diagnosis of toxoplasmic encephalitis or other CNS infection causing focal contrast-enhancing brain lesions
- Pregnancy or currently breast feeding
- Have any other condition that the research team considers a contraindication to participating in the study, e.g. severe cardiac, renal, or pulmonary dysfunction.
- Weight greater than 400 lb for PET and 500 lb for SPECT (limit of the gantry).
Exclusion
Key Trial Info
Start Date :
September 20 2005
Trial Type :
OBSERVATIONAL
End Date :
April 15 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00226304
Start Date
September 20 2005
End Date
April 15 2009
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892