Overview
Sponsor-declared trial summary
Thoracic neoplasm
To qualitatively and quantitatively compare two iodinated contrast administration protocols in oncologic staging CT studies of thoracic tumors, one using half the contrast dose and the other the standard dose, by analyzing the following parameters: vascular attenuation and signal-to-noise ratio (pulmonary arteries and …
Key facts
- Sponsor
- Fundacion De La Comunitat Valenciana Para La Gestion Del Instituto De Investigacion Sanitaria Y Biomedica De Alicante
- 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]
- Decision date (initial)
- 2026-03-17
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To qualitatively and quantitatively compare two iodinated contrast administration protocols in oncologic staging CT studies of thoracic tumors, one using half the contrast dose and the other the standard dose, by analyzing the following parameters: vascular attenuation and signal-to-noise ratio (pulmonary arteries and aorta), hepatic attenuation and signal-to-noise ratio, and subjective assessment of overall image quality and image noise.
Secondary objectives 1
- To assess the inter-reader agreement between two readers in the evaluation of the analyzed parameters.
Conditions and MedDRA coding
Thoracic neoplasm
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- All consecutive patients older than 18 years referred to our department for contrast-enhanced thoracoabdominopelvic CT for staging of a primary pulmonary or pleural malignancy, either at initial diagnosis or during disease follow-up, will be included.
Exclusion criteria 7
- Patients with known allergy or hypersensitivity to iodinated contrast media and/or any of its excipients.
- Renal insufficiency with an estimated glomerular filtration rate (eGFR) <30 mL/min.
- Patient refusal to participate in the study or inability to provide informed consent.
- Incomplete administration of contrast medium according to the assigned protocol due to issues with venous access, injector malfunction, central venous access, or related technical problems.
- Body weight <50 kg or >90 kg.
- Inability to perform the examination on the spectral CT scanner due to equipment malfunction, unavailability, or related technical issues.
- Pregnant women or women with a possibility of being pregnant.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Vascular attenuation and signal-to-noise ratio.
- Hepatic attenuation and signal-to-noise ratio.
- Subjective assessment of overall image quality and image noise.
Secondary endpoints 1
- To analyze the agreement between two readers in the assessment of the evaluated parameters.
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 INJECTION
- Max daily dose
- 100 g/l gram(s)/litre
- Max total dose
- 100 g/l gram(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
Fundacion De La Comunitat Valenciana Para La Gestion Del Instituto De Investigacion Sanitaria Y Biomedica De Alicante
- Sponsor organisation
- Fundacion De La Comunitat Valenciana Para La Gestion Del Instituto De Investigacion Sanitaria Y Biomedica De Alicante
- Address
- Edificio Gris, Avenida Pintor Baeza 12 Avenida Pintor Baeza 12
- City
- Alicante
- Postcode
- 03010
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion De La Comunitat Valenciana Para La Gestion Del Instituto De Investigacion Sanitaria Y Biomedica De Alicante
- Contact name
- David Ferrandez Ferrandez
Public contact point
- Organisation
- Fundacion De La Comunitat Valenciana Para La Gestion Del Instituto De Investigacion Sanitaria Y Biomedica De Alicante
- Contact name
- David Ferrandez Ferrandez
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 52 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
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_2025-524901-33-00 v2 | 2 |
| Recruitment arrangements (for publication) | K1_recruitmemt arrangement_2025-524901-33-00 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_Materials_2025-524901-33-00 | 1 |
| Subject information and informed consent form (for publication) | L1_HIP_2025-524901-33-00 | 1 |
| Subject information and informed consent form (for publication) | L1_IC_2025-524901-33-00 | 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 |
| Synopsis of the protocol (for publication) | Synopsis_CTIS _EN | 1 |
| Synopsis of the protocol (for publication) | Synopsis_CTIS_ES | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-17 | Spain | Acceptable 2026-03-13
|
2026-03-17 |