Study of Methodologies to Measure Blood Flow and Oxygenation in Adults With Sickle Cell Disease
16. december 2020 opdateret af: Bioverativ Therapeutics Inc.
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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
38
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Research Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Participants with mild to severe VOC
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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Part A
Cohort 1- Participants with severe SCD (4-10 VOC/year) Cohort 2- Participants with milder SCD (<4-10 VOC/year) Cohort 3- Healthy volunteers Part A and B can occur in parallel
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Part B
Adults with SCD receiving chronic red blood cell exchange transfusion Part A and B can occur in parallel
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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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)
Tidsramme: Up to day 18 post screening visit
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Up to day 18 post screening visit
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Kidney blood flow rates as assessed by MRI-SWI (susceptibility-weighted imaging)
Tidsramme: Up to day 21 post screening visit
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Up to day 21 post screening visit
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Skeletal muscle blood flow rates as assessed by NIRS
Tidsramme: Up to day 21 post screening visit
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Up to day 21 post screening visit
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Skin blood flow rates as assessed by LSCI
Tidsramme: Up to day 21 post screening visit
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Up to day 21 post screening visit
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Retinal blood flow rates as assessed by OI
Tidsramme: Up to day 21 post screening visit
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Up to day 21 post screening visit
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Total oxygen levels in the brain as assessed by MRI-ASL
Tidsramme: Up to day 21 post screening visit
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Up to day 21 post screening visit
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Total oxygen levels in the kidney as assessed by MRI-SWI
Tidsramme: Up to day 21 post screening visit
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Up to day 21 post screening visit
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Total oxygen levels in the muscle as assessed by NIRS
Tidsramme: Up to day 21 post screening visit
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Up to day 21 post screening visit
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Total oxygen levels in the skin as assessed by LSCI
Tidsramme: Up to day 21 post screening visit
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Up to day 21 post screening visit
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Total oxygen levels in the retina as assessed by OI
Tidsramme: Up to day 21 post screening visit
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Up to day 21 post screening visit
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Medical Director, Bioverativ Therapeutics Inc.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2015
Primær færdiggørelse (Faktiske)
1. oktober 2016
Studieafslutning (Faktiske)
1. oktober 2016
Datoer for studieregistrering
Først indsendt
16. april 2015
Først indsendt, der opfyldte QC-kriterier
14. maj 2015
Først opslået (Skøn)
19. maj 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. december 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. december 2020
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 996SC001
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