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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447627
• Other study ID #: 996SC001
• Status: Completed
• Start date: June 2015
• Est. completion date: October 2016

Study information

• Verified date: August 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Healthy
• Sickle Cell Disease

Locations

Country	Name	City	State
United States	Research Site	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Bioverativ Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood flow in the brain of adults with severe SCD (4-10 vaso-occlusive crises [VOC]/ year) compared to healthy adults without SCD as assessed by MRI-ASL (arterial spin labeling)		Up to day 18 post screening visit
Secondary	Kidney blood flow rates as assessed by MRI-SWI (susceptibility-weighted imaging)		Up to day 21 post screening visit
Secondary	Skeletal muscle blood flow rates as assessed by NIRS		Up to day 21 post screening visit
Secondary	Skin blood flow rates as assessed by LSCI		Up to day 21 post screening visit
Secondary	Retinal blood flow rates as assessed by OI		Up to day 21 post screening visit
Secondary	Total oxygen levels in the brain as assessed by MRI-ASL		Up to day 21 post screening visit
Secondary	Total oxygen levels in the kidney as assessed by MRI-SWI		Up to day 21 post screening visit
Secondary	Total oxygen levels in the muscle as assessed by NIRS		Up to day 21 post screening visit
Secondary	Total oxygen levels in the skin as assessed by LSCI		Up to day 21 post screening visit
Secondary	Total oxygen levels in the retina as assessed by OI		Up to day 21 post screening visit