Overview
Sponsor-declared trial summary
pulmonary embolism
By measuring attenuation at pulmonary arteries, quality of perfusion maps and the diagnostic accuracy for pulmonary thromboembolism we aim to qualitatively and quantitatively compare three protocols for the administration of iodinated contrast in pulmonary CT angiography, one with 20 mL of contrast medium diluted with …
Key facts
- Sponsor
- Hospital General Universitario Dr. Balmis
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 11 Nov 2024 → 1 Aug 2025
- Decision date (initial)
- 2024-10-16
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- INSTITUTO DE INVESTIGACIÓN SANITARIA Y BIOMÉDICA DE ALICANTE ISABIAL
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
By measuring attenuation at pulmonary arteries, quality of perfusion maps and the diagnostic accuracy for pulmonary thromboembolism we aim to qualitatively and quantitatively compare three protocols for the administration of iodinated contrast in pulmonary CT angiography, one with 20 mL of contrast medium diluted with 20 mL of saline, another with 30 mL and another with 40 mL of iodinated contrast.
Secondary objectives 1
- To compare the incidence of contrast-induced nephropathy among the three protocols.
Conditions and MedDRA coding
pulmonary embolism
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10037377 | Pulmonary embolism | 100000004855 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients referred to our department for a pulmonary CT angiography to rule out pulmonary thromboembolism.
Exclusion criteria 4
- Allergic to iodinated contrast
- Renal failure with estimated glomerular filtration rate <30 mL/min
- Patient refusal to participate in the study
- Weight less than 50 or more than 100 kg respectively
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Attenuation achieved in the pulmonary arteries at conventional and low-energy monoenergetic images
- Detection of pulmonary thromboembolism
- Lung perfusion based in iodine density.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Iomeron 400 mgI/ml solution for injection
PRD5911714 · Product
- Active substance
- Iomeprol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 40 mg/l milligram(s)/litre
- Max total dose
- 40 mg/l milligram(s)/litre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08AB10 — IOMEPROL
- Marketing authorisation
- PA1826/006/006
- MA holder
- BRACCO IMAGING S.P.A.
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital General Universitario Dr. Balmis
- Sponsor organisation
- Hospital General Universitario Dr. Balmis
- Address
- Avinguda Del Pintor Baeza 12
- City
- Alicante
- Postcode
- 03010
- Country
- Spain
Scientific contact point
- Organisation
- Hospital General Universitario Dr. Balmis
- Contact name
- Juan José Arenas Jiménez
Public contact point
- Organisation
- Hospital General Universitario Dr. Balmis
- Contact name
- Juan José Arenas Jiménez
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 150 | 1 |
| 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 |
|---|---|---|---|---|---|
| Spain | 2024-11-11 | 2025-08-01 | 2024-11-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Final results SUM-125043
|
2026-03-24T21:43:41 | Submitted | Summary of Results |
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_protocol_EN 2024-515246-17-00 updated 02 | 1 |
| Recruitment arrangements (for publication) | K1_recruitmemt arrangement | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and CIF ADULTS | 2 |
| Subject information and informed consent form (for publication) | L1_SIS HOJA INFORMACION PACIENTE | 1 |
| Subject information and informed consent form (for publication) | L2_CONTRAST ADMINISTRATION TOMOGRAFIA COMPUTARIZADA CON CONTRASTE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | FICHA IOMERON | 1 |
| Summary of results (for publication) | trial publication | 1 |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_EN 2024-515246-17-00 | 1 |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_SP 2024-515246-17-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-06 | Spain | Acceptable 2024-10-16
|
2024-10-16 |