Study of Methodologies to Measure Blood Flow and Oxygenation in Adults With Sickle Cell Disease



Status:Completed
Conditions:Healthy Studies, Anemia
Therapuetic Areas:Hematology, Other
Healthy:No
Age Range:18 - 45
Updated:4/17/2018
Start Date:June 2015
End Date:October 2016

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A Study of Methodologies to Measure Blood Flow and Oxygenation as Potential Biomarkers in Adults With Sickle Cell Disease

The purpose of the study is to determine whether imaging techniques, such as magnetic
resonance imaging (MRI), near infrared spectroscopy (NIRS), laser speckle contrast imaging
(LSCI), and optical imaging (OI), can detect differences in blood flow and oxygen levels in
different organ systems of participants with sickle cell disease (SCD). Differences in blood
flow and oxygen levels detected by these techniques will be evaluated to determine their
utility as biomarkers of clinical disease pathophysiology.


Key Inclusion Criteria:

1. Have a diagnosis of SCD confirmed by hemoglobin analysis.

2. Be in stable clinical condition, as determined by the Investigator.

Subjects enrolled in Part B must also meet the following eligibility criterion at
Screening:

3. Receiving scheduled standard of care RBC exchange transfusion therapy, with ≥3
transfusions already received.

4. Be deemed healthy, as determined by the Investigator, based on the physical
examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and
clinical laboratory measurements.

Key Exclusion Criteria:

1. Inability to lie still for ≥5 minutes, claustrophobia sufficient to interfere with
generating reliable MRI scans, body weight exceeding 320.0 lbs., or girth exceeding
the magnet bore.

2. Presence of a metal device affected by MRI (e.g., any type of electronic, mechanical
or magnetic implant, cardiac pacemaker, aneurysm clips, implanted cardiac
defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings,
other metal objects) which would be a contraindication for MRI.

3. Acute pain crisis requiring hospitalization, with a discharge ≤4 weeks prior to the
first imaging visit, or when determined by the Investigator to not be at steady state.

4. Recent (≤3 months) treatment with hydroxyurea therapy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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