State Of The Art Functional Imaging In Sickle Cell Disease
| Status: | Completed |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 5 - 19 |
| Updated: | 8/25/2018 |
| Start Date: | September 2010 |
| End Date: | June 2016 |
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.
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.
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.
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.
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.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Kathleen J Helton, M.D
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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