Status:
COMPLETED
State Of The Art Functional Imaging In Sickle Cell Disease
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Sickle Cell Anemia
Eligibility:
All Genders
5-19 years
Brief Summary
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 ...
Detailed Description
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 stab...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Pre-Hydroxyurea or Pre-Transfusion Therapy Study Participants:
- The diagnosis of HbSS or HbS/ß0-thalassemia
- Age: 8.0 -- \<19 years old
- Inclusion Criteria for Study Participants for Observation:
- The diagnosis of HbSS or HbS/ß0-thalassemia
- Age: 8.0 -- \<19 years old
- Inclusion Criteria for Study Participants for Family Related Controls:
- No diagnosis of HbSS or HbS/ß0-thalassemia
- Age: 8.0 -- \<19 years old
- Exclusion Criteria for Pre-Hydroxyurea or Pre-Transfusion Therapy Study Participants:
- Unable to tolerate the anatomical or fMRI \[functional magnetic resonance imaging\] without sedation or anesthesia
- Currently receiving hydroxyurea therapy or transfusion therapy
- Previous stem cell transplant or other myelosuppressive therapy
- History of clinical stroke
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent.
- Exclusion Criteria for Study Participants for Observation:
- Unable to tolerate anatomical or fMRI components without sedation or anesthesia
- Currently receiving hydroxyurea or transfusion therapy
- Previous stem cell transplant or other myelosuppressive therapy
- History of clinical stroke
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
- Exclusion Criteria for Study Participants for Family Related Controls:
- Unable to tolerate anatomical or fMRI components without sedation or anesthesia
- Currently receiving hydroxyurea or transfusion therapy
- Previous stem cell transplant or other myelosuppressive therapy
- History of clinical stroke
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01137721
Start Date
September 1 2010
End Date
June 1 2016
Last Update
August 23 2018
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105