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

NCT06907693 | Completed

• 1 other identifier: 2282898
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pulmonary Arterial Hypertension

Keywords

FLUIDDA FRI; FRI

Outcome Measures

Primary Outcomes (1)

• Ratio of BV5A to BV10A

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

  From baseline CT scan to 12 month CT scan

Secondary Outcomes (2)

• Ratio of BV5A to BV5APR

  From baseline CT scan to 12 month CT scan

• Ratio of BV5A to BV5APRA

  From baseline CT scan to 12 month CT scan

Study Arms (1)

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

CT Pulmonary Angiography Scan DIAGNOSTIC_TEST

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

CT Pulmonary Angiography Recipient

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Participation in the CS1-004 clinical trial

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• Cereno Scientific AB: collaborator

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 2, 2025
• Study Start: March 14, 2025
• Primary Completion: December 4, 2025
• Study Completion: April 9, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)