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CompletedNCT06907693Updated Apr 13, 2026

The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI

An observational study in Pulmonary Arterial Hypertension, sponsored by Prisma Health-Upstate. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Prisma Health-Upstate · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7
Sex
All
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Study summary

Explore the impact of drug candidate CS1 on pathological vascular remodeling of small pulmonary arteries in the disease pulmonary arterial hypertension (PAH). This sub-study for CS1-004 aims to utilize FRI, an innovative, non-invasive imaging technology to visualize how long-term use of CS1 influences structural changes in pulmonary arteries. This sub-study seeks to provide valuable insights into the potential of CS1 to transform PAH treatment in some patients enrolled in the Expanded Access Program (CS1-004).

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Conditions studied

  • Pulmonary Arterial Hypertension

Keywords

  • FLUIDDA FRI
  • FRI
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In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 7 is below the median of 100 across 197 observational studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Prisma Health-Upstate is the lead sponsor of 74 studies on the registry; 7 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participation in the CS1-004 clinical trial at Prisma Health-Upstate

Inclusion criteria

  • Participation in the CS1-004 clinical trial

Exclusion criteria

Exclusion Criteria:

  • Inability to undergo a CT pulmonary angiography scan (i.e., claustrophobia)
  • Individuals who are pregnant or who become pregnant during the sub-study
  • eGFR \<30 mL/min/1.73m2 as calculated by Modification of Diet in Renal Disease (MDRD)
  • Allergy to Iodine contrast agents
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7 participants (actual)
Patient registry
No

Groups and cohorts

  • CT Pulmonary Angiography Recipient

    All subjects in this study will undergo CT pulmonary angiography scans at baseline (+/- 2 months from start of drug therapy), 4 months and 12 months.

    Diagnostic Test: CT Pulmonary Angiography Scan

Interventions

  • Diagnostic testCT Pulmonary Angiography Scan

    Computed tomography (CT) pulmonary angiography scan of the chest with IV contrast

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What researchers measure

Primary outcomes

  1. Ratio of BV5A to BV10A

    Change from baseline to month 12 in the ratio BV5A/BV10A

    Time frame: From baseline CT scan to 12 month CT scan

Secondary outcomes

  1. Ratio of BV5A to BV5APR

    Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APR variable.

    Time frame: From baseline CT scan to 12 month CT scan

  2. Ratio of BV5A to BV5APRA

    Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APRA variable.

    Time frame: From baseline CT scan to 12 month CT scan

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Study locations

1 site
  • Prisma Health
    Greenville, South Carolina 29605, United States
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References and documents

Publications

  • 1. US EPA O. Frequent Questions: Radiation in Medicine. www.epa.gov. Published December 4, 2023. https://www.epa.gov/radiation/frequent-questions-radiation-medicine

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06907693
Lead sponsor
Prisma Health-Upstate
Collaborators
Cereno Scientific AB
Responsible party
Sponsor
First posted
Apr 2, 2025
Start date
Mar 14, 2025
Primary completion
Dec 4, 2025
Completion
Apr 9, 2026
Last update
Apr 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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