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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00029926 |
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Date of registration:
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26/01/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Positron Emission Tomography (PET) to Locate Areas of White Blood Cell Activity
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Scientific title:
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A Pilot Study of F-18FDG Positron Emission Tomography (PET) to Assess the Distribution of Activated Lymphocytes in Systemic Lupus Erythematosus (SLE) |
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Date of first enrolment:
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January 2002 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00029926 |
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Study type:
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Observational |
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Study design:
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N/A
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Phase:
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N/A
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Subjects must be at least 18 years of age at time of entry.
Subjects must have the ability to give written informed consent prior to entry in the
protocol.
Subjects must fulfill at least 4 criteria for SLE as defined by the American College of
Rheumatology.
Patient's with a body habitus not allowing for PET scanning due to technical reasons
(weight exceeding 299 pounds or 136 kg) will be excluded.
Subjects with concurrent diseases that may alter lymphocyte activation (e.g. -sarcoidosis,
chronic inflammatory diseases, asthma) will not be eligible.
Pregnant and lactating women will be excluded. Women of childbearing potential are
required to have a negative pregnancy test.
Subjects with active severe CNS lupus (encephalopathy, cerebrovascular accident,
transverse myelitis, severe depression, psychosis) will be excluded.
Subjects with a history of malignancy or current malignancy with the exception of basal
cell carcinoma of the skin will be excluded.
Subjects with viral or acute bacterial infection within 3 weeks of the study will be
excluded.
Subjects with an active infection will be excluded.
Subjects with active hepatitis B, hepatitis C or HIV infection will be excluded.
Subjects with generalized lymphadenopathy (more than 3 anatomical regions) will be
excluded.
Subjects with diabetes mellitus will be excluded.
Subjects with a splenectomy will be excluded.
Subjects with a poor venous access will be excluded.
Subjects with a SLEDAI (Systemic lupus erythematosus disease activity index) score of
greater than 2 and less than 8 will be excluded.
Subjects with a significant concurrent medical condition that, in the opinion of the
principal investigator, could affect the patient's ability to tolerate or complete the
study will be excluded.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic
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Lupus Erythematosus
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Intervention(s)
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Drug: 2-deoxy-2 [F-18] fluoro-2-d-glucose
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Secondary ID(s)
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02-AR-0114
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020114
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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