Sickle Cell Anemia Clinical Trial
Official title:
State Of The Art Functional Imaging In Sickle Cell Disease
NCT number | NCT01137721 |
Other study ID # | SCDMR4 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2010 |
Est. completion date | June 2016 |
Verified date | August 2016 |
Source | St. Jude Children's Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Sickle cell anemia (SCA) is a serious blood disease with blood vessel changes leading to brain injury and stroke. Studies show about 11% of patients with SCA will develop obvious stroke before age 20 years, with children less than 10 years of age especially vulnerable. The main objective of the SCDMR4[State Of The Art Functional Imaging In Sickle Cell Disease] trial is to compare the gray matter cerebral blood flow, measured by MRI,[magnetic resonance imaging] ASL [Arterial Spin Labeling] perfusion before treatment begins and after the appropriate hydroxyurea dosage is reached (~ one year). Other important objectives of the SCDMR4 trial include describing the effect of hydroxyurea therapy and transfusion therapy on the functional MRI response, diffusion tensor imaging of white matter, brain function, and transcranial Doppler blood velocities.
Status | Completed |
Enrollment | 38 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 19 Years |
Eligibility |
Inclusion Criteria for Pre-Hydroxyurea or Pre-Transfusion Therapy Study Participants: 1. The diagnosis of HbSS or HbS/ß0-thalassemia 2. Age: 8.0 -- <19 years old Inclusion Criteria for Study Participants for Observation: 1. The diagnosis of HbSS or HbS/ß0-thalassemia 2. Age: 8.0 -- <19 years old Inclusion Criteria for Study Participants for Family Related Controls: 1. No diagnosis of HbSS or HbS/ß0-thalassemia 2. Age: 8.0 -- <19 years old Exclusion Criteria for Pre-Hydroxyurea or Pre-Transfusion Therapy Study Participants: 1. Unable to tolerate the anatomical or fMRI [functional magnetic resonance imaging] without sedation or anesthesia 2. Currently receiving hydroxyurea therapy or transfusion therapy 3. Previous stem cell transplant or other myelosuppressive therapy 4. History of clinical stroke 5. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent. Exclusion Criteria for Study Participants for Observation: 1. Unable to tolerate anatomical or fMRI components without sedation or anesthesia 2. Currently receiving hydroxyurea or transfusion therapy 3. Previous stem cell transplant or other myelosuppressive therapy 4. History of clinical stroke 5. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. Exclusion Criteria for Study Participants for Family Related Controls: 1. Unable to tolerate anatomical or fMRI components without sedation or anesthesia 2. Currently receiving hydroxyurea or transfusion therapy 3. Previous stem cell transplant or other myelosuppressive therapy 4. History of clinical stroke 5. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in cerebral blood flow | 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. | from baseline to 12 +/- 3 months | |
Secondary | Change in cerebral blood flow by territory | 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. | From baseline to 12 +/- 3 months |
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