Overview
Sponsor-declared trial summary
Progressive Fibrosing Interstitial Lung Diseases
This project aims to investigate the potential of non-invasive imaging to identify and monitor the earliest signs and physiological effects of pulmonary fibrosis and resulting cardiac dysfunction in patients with fibrosing interstitial lung disease. Second, to evaluate baseline risk factors the progression and therapeu…
Key facts
- Sponsor
- Aarhus University
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Trial duration
- 2 Oct 2023 → ongoing
- Decision date (initial)
- 2023-03-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Karen Elise Jensens Fond · Aarhus University
External identifiers
- EU CT number
- 2022-502512-36-00
- WHO UTN
- U1111-1284-7436
- ClinicalTrials.gov
- NCT05914506
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis
This project aims to investigate the potential of non-invasive imaging to identify and monitor the earliest signs and physiological effects of pulmonary fibrosis and resulting cardiac dysfunction in patients with fibrosing interstitial lung disease. Second, to evaluate baseline risk factors the progression and therapeutic responses to anti-fibrotic drugs.
Conditions and MedDRA coding
Progressive Fibrosing Interstitial Lung Diseases
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patients diagnosed with IPF or fibrotic ILD who fulfills PPF criteria, and are prescribed antifibrotic treatment.
- Age 18-90
- Cognitively able to understand and participate in the study
- Pre-menopausal women must be confirmed non-pregnant by an onsite test.
Exclusion criteria 7
- Contraindications for MRI (Pacemaker, neurostimulator or cochlear implant; Metal foreign bodies such as fragments and irremovable piercings; Unsafe medical implants (safety of heart valves, hips and the like must be confirmed); Intrathoracic clips or coils; Cardiac pacemakers; Claustrophobia; Largest circumference including arms > 160 cm)
- Contraindications to gadolinium contrast (eGFR < 30 mL/min/1.73m2; Previous adverse reactions to gadolinium)
- Overlapping emphysematic disease where the emphysema-component outweighs the fibrosis
- Unable to perform breath-hold of minimum 20 seconds.
- Allergy to Xenon
- Breast feeding
- Evidence of ongoing respiratory infections at time of MR examinations
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- MR xenon ventilation and dissolved parameters
- Worsening of pulmonary function test parameters
- Worsening of HRCT parameters
- Worsening in patient reported symptoms
Secondary endpoints 3
- Regionally decreased perfusion
- Evidence of myocardial stran and fibrosis
- Late contrast enhancement
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
PRD10485548 · Product
- Active substance
- Xenon (129XE)
- Pharmaceutical form
- INHALATION SOLUTION
- Route of administration
- INHALATION
- Max daily dose
- 12 l litre(s)
- Max total dose
- 12 l litre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AARHUS UNIVERSITY
- Paediatric formulation
- No
- Orphan designation
- No
PRD10485529 · Product
- Active substance
- Xenon (129XE)
- Pharmaceutical form
- INHALATION SOLUTION
- Route of administration
- INHALATION
- Max daily dose
- 12 l litre(s)
- Max total dose
- 12 l litre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AARHUS UNIVERSITY
- Paediatric formulation
- No
- Orphan designation
- No
PRD10485562 · Product
- Active substance
- Xenon (129XE)
- Pharmaceutical form
- INHALATION SOLUTION
- Route of administration
- INHALATION
- Max daily dose
- 12 l litre(s)
- Max total dose
- 12 l litre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AARHUS UNIVERSITY
- Paediatric formulation
- No
- Orphan designation
- No
Hyperpolarised 129Xe gas 1000 ml
PRD10485456 · Product
- Active substance
- Xenon (129XE)
- Pharmaceutical form
- INHALATION SOLUTION
- Route of administration
- INHALATION
- Max daily dose
- 12 l litre(s)
- Max total dose
- 12 l litre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AARHUS UNIVERSITY
- Paediatric formulation
- No
- Orphan designation
- No
PRD10485510 · Product
- Active substance
- Xenon (129XE)
- Pharmaceutical form
- INHALATION SOLUTION
- Route of administration
- INHALATION
- Max daily dose
- 12 l litre(s)
- Max total dose
- 12 l litre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AARHUS UNIVERSITY
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 1
Gadovist, injektionsvæske, opløsning
PRD385362 · Product
- Active substance
- Gadobutrol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 20 ml millilitre(s)
- Max total dose
- 40 ml millilitre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08CA09 — GADOBUTROL
- Marketing authorisation
- 31449
- MA holder
- BAYER AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus University
- Sponsor organisation
- Aarhus University
- Address
- Palle Juul-Jensens Boulevard 82
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus University
- Contact name
- Mattias Kristensen
Public contact point
- Organisation
- Aarhus University
- Contact name
- Mattias Kristensen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus University ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 8 |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 39 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-10-02 | 2023-10-05 | 2025-11-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol 129Xe MR IPF | 7.0 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 2 |
| Subject information and informed consent form (for publication) | Fr du beslutter dig | 1 |
| Subject information and informed consent form (for publication) | Interview Guide 2022-502512-36-00 | 1 |
| Subject information and informed consent form (for publication) | K-BILD | 1 |
| Subject information and informed consent form (for publication) | L-PF Impacts | 1 |
| Subject information and informed consent form (for publication) | L-PF Symptoms | 1 |
| Subject information and informed consent form (for publication) | Patientinformation | 4.1 |
| Subject information and informed consent form (for publication) | Patientsamtykke | 3 |
| Subject information and informed consent form (for publication) | SOBQ | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis | 4 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-11 | Denmark | Acceptable 2023-03-06
|
2023-03-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-11-10 | Denmark | Acceptable 2024-01-12
|
2024-01-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-09 | Denmark | Acceptable 2025-01-31
|
2025-01-31 |