Pulmonary Arterial HypertensionNCT06907693
The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI
An observational study of Pulmonary Arterial Hypertension, run by Prisma Health-Upstate at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- CT Pulmonary Angiography Scan
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2025to 9 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participation in the CS1-004 clinical trial at Prisma Health-Upstate
Who may be able to join
- Participation in the CS1-004 clinical trial
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- CT Pulmonary Angiography Scan
- Keywords
- FLUIDDA FRI, FRI
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Pulmonary Angiography ScanDiagnostic test
Computed tomography (CT) pulmonary angiography scan of the chest with IV contrast
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: CT Pulmonary Angiography Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of BV5A to BV10A
Change from baseline to month 12 in the ratio BV5A/BV10A
Measured: From baseline CT scan to 12 month CT scan
Secondary outcomes (2)
Ratio of BV5A to BV5APR
Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APR variable.
Measured: From baseline CT scan to 12 month CT scan
Ratio of BV5A to BV5APRA
Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APRA variable.
Measured: From baseline CT scan to 12 month CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start14 Mar 2025
- Primary completion4 Dec 2025
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Cereno Scientific AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907693
- Sponsor's protocol ID
- 2282898
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI, a Non-Invasive, Functional Respiratory Imaging System
- ClinicalTrials.gov ID
- NCT06907693
- Acronym / sponsor ID
- 2282898
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- FLUIDDA FRI, FRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Cereno Scientific AB
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT Pulmonary Angiography Recipient | – | Diagnostic Test: CT Pulmonary Angiography ScanAll subjects in this study will undergo CT pulmonary angiography scans at baseline (+/- 2 months from start of drug therapy), 4 months and 12 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participation in the CS1-004 clinical trial at Prisma Health-Upstate
Key inclusion criteria (1 listed)
- Participation in the CS1-004 clinical trial
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT Pulmonary Angiography ScanComputed tomography (CT) pulmonary angiography scan of the chest with IV contrast | Diagnostic test | CT Pulmonary Angiography Recipient |
Primary outcome
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
2 secondary outcomes
Ratio of BV5A to BV5APR
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background1. 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 dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of BV5A to BV10A (time frame: From baseline CT scan to 12 month CT scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06907693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.