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Completed

NCT Number: NCT02447627

Study of Methodologies to Measure Blood Flow and Oxygenation 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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Detroit, Michigan, 48201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Have a diagnosis of SCD confirmed by hemoglobin analysis.
  • Be in stable clinical condition, as determined by the Investigator.

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

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

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

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

Treatment and study plan

Primary outcomes

  1. 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)

    Time frame: Up to day 18 post screening visit

Secondary outcomes

  1. Kidney blood flow rates as assessed by MRI-SWI (susceptibility-weighted imaging)

    Time frame: Up to day 21 post screening visit

  2. Skeletal muscle blood flow rates as assessed by NIRS

    Time frame: Up to day 21 post screening visit

  3. Skin blood flow rates as assessed by LSCI

    Time frame: Up to day 21 post screening visit

  4. Retinal blood flow rates as assessed by OI

    Time frame: Up to day 21 post screening visit

  5. Total oxygen levels in the brain as assessed by MRI-ASL

    Time frame: Up to day 21 post screening visit

  6. Total oxygen levels in the kidney as assessed by MRI-SWI

    Time frame: Up to day 21 post screening visit

  7. Total oxygen levels in the muscle as assessed by NIRS

    Time frame: Up to day 21 post screening visit

  8. Total oxygen levels in the skin as assessed by LSCI

    Time frame: Up to day 21 post screening visit

  9. Total oxygen levels in the retina as assessed by OI

    Time frame: Up to day 21 post screening visit

Sponsors and collaborators

Lead sponsor

Bioverativ Therapeutics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 19, 2015
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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