Non-Invasive Infrared Spectroscopy for Sickle Cell Disease

Overseen By Dianna Lovins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Must be taking: Hydroxyurea

Must not be taking: Oxbryta, Adakveo, Endari

Disqualifiers: Pregnancy, Mobility difficulties, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to monitor sickle cell disease (SCD) using near infrared spectroscopy (NIRS). SCD is a blood disorder that can cause severe pain and organ damage. Researchers aim to determine if NIRS can effectively measure important signs like oxygen levels and blood flow. The trial seeks individuals with SCD who have maintained a stable dose of Hydroxyurea for at least 90 days. Healthy volunteers are also needed for comparison. Participants will undergo non-invasive tests, including NIRS, heart ultrasound, and a walking test. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance monitoring techniques for SCD.

Will I have to stop taking my current medications?

If you are taking Hydroxyurea, you must be on a stable dose for 90 days before the trial. You cannot participate if you have used Oxbryta, Adakveo, or Endari in the 12 weeks before signing consent.

What prior data suggests that this imaging technique is safe for monitoring sickle cell disease?

Research has shown that near infrared spectroscopy (NIRS) is safe for humans. Studies have found that NIRS effectively measures brain oxygen levels and blood flow. It uses light to examine tissues, avoiding needles or radiation.

In past studies with sickle cell disease patients, researchers used NIRS to monitor brain blood flow and oxygen without any serious side effects. The technique is non-invasive, meaning it doesn't enter the body, which generally makes it easy to tolerate. No reports of negative effects have been linked to NIRS in these cases.

Overall, evidence suggests that NIRS is a safe and gentle way to check blood and tissue health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Near Infrared Spectroscopy (NIRS) for sickle cell disease because it offers a non-invasive way to monitor blood and tissue health. Unlike standard treatments like hydroxyurea or blood transfusions, which manage symptoms and complications, NIRS provides real-time insights into the body's oxygen levels without needing needles or blood draws. This could lead to better, more personalized care by allowing doctors to quickly detect issues before they become serious.

What evidence suggests that near infrared spectroscopy is effective for monitoring sickle cell disease?

Studies have shown that near infrared spectroscopy (NIRS) effectively detects differences in blood flow and oxygen levels between individuals with sickle cell disease (SCD) and healthy individuals. Research indicates that NIRS sensitively tracks changes in blood movement and oxygen transport in SCD patients. Specifically, it has monitored blood flow in tiny brain vessels, revealing how SCD impacts these areas. This trial will use NIRS as a non-invasive method to track these changes, offering valuable insights into the effects of SCD on the body. ^{3 6 7 8 9}

Who Is on the Research Team?

Swee Lay Thein, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

This trial is for adults with Sickle Cell Disease (SCD), including those on stable Hydroxyurea treatment. Healthy individuals are also needed for comparison. Pregnant women, people who can't walk for 6 minutes due to mobility issues, recent users of certain SCD medications, and those with specific surgical histories or blood transfusions are excluded.

Inclusion Criteria

I have been taking a consistent dose of Hydroxyurea for the last 90 days.

I am willing and able to give my consent for treatment.

I am 18 or older with an HbAA genotype.

Exclusion Criteria

I have not had a blood transfusion in the last 60 days or an exchange transfusion in the last 90 days.

Ethnically matched controls: Women who are currently pregnant

I have had a blood transfusion within the last 60 days or an exchange transfusion within the last 90 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Baseline Assessment

Participants undergo NIRS testing, ultrasound exam, and a 6-minute walk test to assess baseline hemodynamics and cardiovascular health

1 visit

1 visit (in-person)

Optional Follow-up Visits

Participants may return for up to 4 additional visits for NIRS testing to assess repeatability of measurements

Up to 120 days

Up to 4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after initial assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Near Infrared Spectroscopy (NIRS)

Trial Overview Researchers are testing Near Infrared Spectroscopy (NIRS) as a non-invasive method to measure muscle oxygen levels, blood flow, and tissue composition in patients with SCD compared to healthy controls. The study involves physical exams, NIRS tests during various activities, and up to five visits.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

Single-arm study

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Citations

1. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/3862/502501/Exploring-Near-Infrared-Spectroscopy-As-a-Tool-for

Exploring Near Infrared Spectroscopy As a Tool for Monitoring ... The purpose of this study is to show that NIRS is sensitive to differences in tissue hemodynamics between patients with SCD and healthy population.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123104642

Exploring Near Infrared Spectroscopy As a Tool for ... The purpose of this study is to show that NIRS is sensitive to differences in tissue hemodynamics between patients with SCD and healthy population.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12453026/

Assessment of Cerebral Autoregulation and ... - PubMed Central The results revealed that SCD exhibited impaired CA, longer blood transit times, and decreased tissue oxygen saturation compared to healthy ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2950327224000093

Incorporating point-of-care technologies to assess ... Support for this notion comes from near-infrared spectroscopy (NIRS) studies, which noninvasively monitored microvascular cerebral blood flow and compared ...

5. journals.physiology.org journals.physiology.org/doi/10.1152/japplphysiol.00426.2023

Assessment of cerebral autoregulation and ... This study explored near-infrared spectroscopy (NIRS) for monitoring cerebral autoregulation (CA) in patients with sickle cell disease (SCD).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2760387/

Near-infrared spectra absorbance of blood from sickle cell ... Studies using near-infrared spectroscopy (NIRS) have reported that patients with sickle cell disease (SCD) have lower cerebral oxygen saturation values (rSO2) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9966188/

Near-Infrared Spectroscopy Demonstrates the Benefit ... Using NIRS during BET showed that BET improves cerebral perfusion in adult patients with SCD with cerebral vasculopathy.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0006497123090948

Longitudinal Characterization of Hemodynamic Changes ... We evaluate the sensitivity of NIRS technologies to hemodynamic changes in patients with SCD undergoing treatment with mitapivat.

9. thejns.org thejns.org/focus/view/journals/neurosurg-focus/32/2/2011.12.focus11280.xml

Validation of frontal near-infrared spectroscopy as ... Near-infrared spectroscopy offers the advantage of measuring brain tissue arteriovenous oxygenation via an emitted near-infrared light that penetrates the scalp ...