State Of The Art Functional Imaging In Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT01137721|
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : August 2, 2016
|Condition or disease|
|Sickle Cell Anemia|
The Primary Objective of the study is to compare the research participant's GM [Gray Matter] CBF [Cerebral Blood Flow] by ASL [Arterial Spin Labeling] techniques before and after reaching a stable hydroxyurea MTD [Maximum Tolerated Dose] (12±3 months after starting hydroxyurea).
This is an observational study. Participants receive hydroxyurea as part of their standard of care treatment. This study will observe the above measures prior to beginning hydroxyurea and after participants reach the maximum tolerated dose in order to describe the effect of therapy on the participants' functional response.
|Study Type :||Observational|
|Actual Enrollment :||38 participants|
|Observational Model:||Case Control|
|Official Title:||State Of The Art Functional Imaging In Sickle Cell Disease|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Pre-Hydroxyurea - subjects with SCD
Patients with a diagnosis of HbSS (sickle cell anemia) or HbS/ß0-thalassemia (beta thalassemia) who will be treated with hydroxyurea therapy.
Sibling control with no diagnosis of HbSS or HbS/ß0-thalassemia.
Observational - subjects with SCD
Patients with a diagnosis of HbSS or HbS/ß0-thalassemia.
Pre-transfusion - subjects with SCD
Patients with a diagnosis of HbSS or HbS/ß0-thalassemia who will be treated with transfusion therapy.
- Change in cerebral blood flow [ Time Frame: from baseline to 12 +/- 3 months ]Change in gray matter cerebral blood flow measured by arterial spin labeling techniques from before (baseline) to after reaching a stable hydroxyurea maximum tolerated dose.
- Change in cerebral blood flow by territory [ Time Frame: From baseline to 12 +/- 3 months ]Change in gray matter cerebral blood flow in individual anterior cerebral artery, middle cerebral artery, and posterior cerebral artery territories, and hemispheric gray matter measured by arterial spin labeling techniques from before (baseline) to after reaching a stable hydroxyurea maximum tolerated dose.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137721
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Kathleen J Helton, M.D||St. Jude Children's Research Hospital|