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

April 9, 2026 updated by: Prisma Health-Upstate

The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI, a Non-Invasive, Functional Respiratory Imaging System

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Participation in the CS1-004 clinical trial

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Computed tomography (CT) pulmonary angiography scan of the chest with IV contrast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of BV5A to BV10A
Time Frame: From baseline CT scan to 12 month CT scan
Change from baseline to month 12 in the ratio BV5A/BV10A
From baseline CT scan to 12 month CT scan

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of BV5A to BV5APR
Time Frame: From baseline CT scan to 12 month CT scan
Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APR variable.
From baseline CT scan to 12 month CT scan
Ratio of BV5A to BV5APRA
Time Frame: From baseline CT scan to 12 month CT scan
Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APRA variable.
From baseline CT scan to 12 month CT scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Upstate

Collaborators

Cereno Scientific AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2025

Primary Completion (Actual)

December 4, 2025

Study Completion (Actual)

April 9, 2026

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2282898

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Arterial Hypertension

Clinical Trials on CT Pulmonary Angiography Scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe