Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226304
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-09-23
Brief Title:
Evaluation of Brain Lesions in HIV-infected Patients for Diagnosis of Primary Central Nervous System Lymphoma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Evaluation of Focal Contrast-Enhancing Brain Lesions in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2009-04-15
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:
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 patients 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 to therapy Antiretroviral therapy is initiated in patients who are not already on such a regimen
Patients whose test results indicate a high risk for PCNSL have a CT scan to look for evidence of lymphoma elsewhere in the body and are referred for consultation with a neurosurgeon to discuss undergoing a brain biopsy The brain biopsy is done in the operating room under general anesthesia A small cut is made in the scalp and a small opening is made in the skull over the area of the brain to be biopsied A needle is placed in the opening in the skull and guided by CT or MRI moved to the abnormal area of the brain where a small piece of tissue is removed for study under a microscope
Patients found to have toxoplasmosis are discharged from the hospital to the care of their primary care physician after they are getting better and are tolerating all their medications They return to NIH for follow-up visits about 4 weeks and 6 months after discharge
Patients found to have lymphoma are referred to the National Cancer Institute for screening for enrollment in a treatment protocol Patients who are not eligible for a treatment protocol are referred back to their primary care physician or for another NIH treatment protocol if one is available Patients with lymphoma are seen at the NIAID outpatient clinic for follow-up visits and laboratory examinations every 3 months for 2 years
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 patients 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 to therapy Antiretroviral therapy is initiated in patients who are not already on such a regimen
Patients whose test results indicate a high risk for PCNSL have a CT scan to look for evidence of lymphoma elsewhere in the body and are referred for consultation with a neurosurgeon to discuss undergoing a brain biopsy The brain biopsy is done in the operating room under general anesthesia A small cut is made in the scalp and a small opening is made in the skull over the area of the brain to be biopsied A needle is placed in the opening in the skull and guided by CT or MRI moved to the abnormal area of the brain where a small piece of tissue is removed for study under a microscope
Patients found to have toxoplasmosis are discharged from the hospital to the care of their primary care physician after they are getting better and are tolerating all their medications They return to NIH for follow-up visits about 4 weeks and 6 months after discharge
Patients found to have lymphoma are referred to the National Cancer Institute for screening for enrollment in a treatment protocol Patients who are not eligible for a treatment protocol are referred back to their primary care physician or for another NIH treatment protocol if one is available Patients with lymphoma are seen at the NIAID outpatient clinic for follow-up visits and laboratory examinations every 3 months for 2 years
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 toxoplasmic encephalitis The method of choice for establishing the definitive diagnosis is brain biopsy This procedure can be associated with a significant morbidity and mortality and therefore less invasive means of diagnosing cerebral mass lesions have been studied
Currently an accepted standard of care for HIV-infected patients that present with signs and symptoms of focal brain lesions is to empirically treat for toxoplasmic encephalitis Brain biopsy is often deferred until there is demonstration of lack of clinical response or progression on empiric therapy As a result treatment initiation is frequently delayed During this time it is not unusual for further clinical deterioration to occur before appropriate therapies can be initiated Frequently the alternative approaches then become a question of appropriate palliation rather than curative intent therapy
Less invasive diagnostic tests to assist in the diagnosis have been investigated Based on the finding that essentially 100 of HIV-related PCNSL are EBV-associated the detection of EBV DNA by PCR amplification in the cerebrospinal fluid CSF has demonstrated clinical usefulness in the diagnosis as has the use of neuroradiologic imaging to detect the malignancy Prior studies have demonstrated that the use of a combination of neuroradiologic immunologic and clinical variables in the workup of focal brain lesions in HIV-infected patients to be quite accurate in identifying patients in need of brain biopsy but a diagnostic algorithm that incorporates the combination of the most sensitive and specific tests in a timely manner has not yet been explored
This study seeks to evaluate an algorithm for the workup of HIV infected patients with focal brain lesions so as to expedite the diagnosis and subsequent treatment of PCNSL The goals of the study are to 1 determine the specificity sensitivity and positive predictive value of a diagnostic algorithm that entails the use of the combination of EBV detection in the CSF and FDG-PET scanning to diagnose PCNSL 2 evaluate the time to response to anti-toxoplasmic encephalitis therapy and 3 evaluate the sensitivities and specificities of FDG-PET and 201Tl-SPECT scanning in identifying PCNSL Up to one hundred HIV-infected patients with history of at least one focal brain lesion will be screened for enrollment All patients will be treated empirically for toxoplasmic encephalitis until an alternative diagnosis is confirmed All enrolled patients will be treated concurrently with antiretroviral therapy Patients identified to have PCNSL will be referred to the NCI Treatment of PCNSL Protocol for further treatment if the study is open for enrollment
Currently an accepted standard of care for HIV-infected patients that present with signs and symptoms of focal brain lesions is to empirically treat for toxoplasmic encephalitis Brain biopsy is often deferred until there is demonstration of lack of clinical response or progression on empiric therapy As a result treatment initiation is frequently delayed During this time it is not unusual for further clinical deterioration to occur before appropriate therapies can be initiated Frequently the alternative approaches then become a question of appropriate palliation rather than curative intent therapy
Less invasive diagnostic tests to assist in the diagnosis have been investigated Based on the finding that essentially 100 of HIV-related PCNSL are EBV-associated the detection of EBV DNA by PCR amplification in the cerebrospinal fluid CSF has demonstrated clinical usefulness in the diagnosis as has the use of neuroradiologic imaging to detect the malignancy Prior studies have demonstrated that the use of a combination of neuroradiologic immunologic and clinical variables in the workup of focal brain lesions in HIV-infected patients to be quite accurate in identifying patients in need of brain biopsy but a diagnostic algorithm that incorporates the combination of the most sensitive and specific tests in a timely manner has not yet been explored
This study seeks to evaluate an algorithm for the workup of HIV infected patients with focal brain lesions so as to expedite the diagnosis and subsequent treatment of PCNSL The goals of the study are to 1 determine the specificity sensitivity and positive predictive value of a diagnostic algorithm that entails the use of the combination of EBV detection in the CSF and FDG-PET scanning to diagnose PCNSL 2 evaluate the time to response to anti-toxoplasmic encephalitis therapy and 3 evaluate the sensitivities and specificities of FDG-PET and 201Tl-SPECT scanning in identifying PCNSL Up to one hundred HIV-infected patients with history of at least one focal brain lesion will be screened for enrollment All patients will be treated empirically for toxoplasmic encephalitis until an alternative diagnosis is confirmed All enrolled patients will be treated concurrently with antiretroviral therapy Patients identified to have PCNSL will be referred to the NCI Treatment of PCNSL Protocol for further treatment if the study is open for enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-CC-0246 | None | None | None |