Evaluation of the efficacy and safety of Magnetic Resonance Angiography (MRA) using gadopiclenol compared to gadoterate meglumine in the assessment of steno-occlusive disease in adult patients with suspected vascular disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Guerbet, Bracco Imaging S.p.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-04-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bracco Imaging S.p.A · Guerbet

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Diagnosis, Safety

To demonstrate the non-inferiority of gadopiclenol-enhanced Magnetic Resonance Angiography (MRA) at (***) mmol/kg body weight compared to gadoterate meglumine-enhanced MRA at 0.1 mmol/kg body weight in terms of sensitivity and specificity for detecting clinically significant steno-occlusive disease at segment level using Computerized Tomography Angiography (CTA) and/or Intra-arterial-Digital Subtraction Angiography (IA-DSA) findings as Standard of Truth.

Secondary objectives 1

1. To assess the safety profile of gadopiclenol X mmol/kg and gadoterate meglumine 0.1 mmol/kg in terms of incidence of adverse events and changes in vital signs.

Conditions and MedDRA coding

Suspected Vascular Disease of supra-aortic (carotid/vertebrobasilar), peripheral or abdominal/renal arteries

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

IPD plan description

Not applicable

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male or female patients 18 years of age or older willing to participate in the trial and follow all study procedures specified in the protocol.
2. Patient having read the information in the ICF and having provided his/her consent to participate in writing by dating and signing the ICF prior to any trial related procedure being conducted.
3. Patient with suspected steno-occlusive disease in supra-aortic (carotid/vertebrobasilar) (a), peripheral (b) or abdominal/renal (c) arteries based on: a. clinical signs and symptoms including but not limited to prior stroke, transient ischemic attack (TIA), amaurosis fugax (transient monocular blindness) and/or previous diagnostic tests (CTA, IA-DSA, or ultrasound) (***) or b. symptoms of lower-extremity arterial disease (stages II-IV according to the Leriche-Fontaine classification, or 1 to 6 according to Rutherford classification 113 and/or confirmed by previous imaging (Doppler ultrasound, CTA, MRA, IADSA) (***) or c. suspected renovascular hypertension based on one or more of the following criteria: i. hypertension refractory to standard therapy ii. acute worsening of pre-existing hypertension iii. abrupt onset of sustained, moderate to severe hypertension at age <35 years suggestive of fibromuscular dysplasia (FMD) iv. progressive renal insufficiency (creatinine > 2 mg/dL; no other apparent cause of progressive renal failure based on routine medical history, physical examination, 24-h urine collection and urinary protein excretion) v. abnormal/inconclusive renal doppler ultrasound. vi. other criteria (to be specified)
4. Are scheduled for or had undergone CTA and/or IA-DSA according to imaging standards to cover the supra-aortic (carotid/vertebrobasilar) and/or peripheral and/or abdominal/renal territory described in this protocol

Exclusion criteria 11

1. Is a pregnant or lactating female. Exclude the possibility of pregnancy for women of childbearing potential: • by testing on site at the institution (serum βHCG or urine) (***) • by surgical history (e.g., tubal ligation or hysterectomy) • post-menopausal with a minimum 1 year without menses.
2. Has any known allergy to one or more of the ingredients in the investigational products or has a history of hypersensitivity to other GBCAs.
3. Has severe renal impairment defined as an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2 calculated using the Modification of Diet in Renal Disease (MDRD) formula (***).
4. Has known or suspected acute kidney injury (AKI) based on: a. Increase in serum creatinine by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours or b. Increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within prior 7 days or c. Urine volume < 0.5 mL/kg/h for 6 hours
5. Has received any contrast agent (for MRI, CT, DSA) (***) prior to the first IMP administration or is scheduled to receive any contrast agent between the two MRA or (***) after the second IMP administration.
6. Has received or is scheduled for therapeutic intervention (e.g., endovascular therapy, vascular surgery, etc.) of any kind for vascular disease in the arterial territory of interest performed between the 2 MRA procedures or between the study MRAs and the CTA/IADSA procedures when applicable
7. Has any contraindications to MRI.
8. Is suffering from severe claustrophobia.
9. Has received an investigational drug or medical device (***) before admission into this study or scheduled to receive any investigational treatment in the course of the trial.
10. Was previously included in this trial.
11. Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Diagnostic performance indicators, namely sensitivity and specificity for detecting clinically significant steno-occlusive disease of different vascular territories.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Guerbet

Sponsor organisation

Guerbet

Address

15 Rue Des Vanesses

City

Villepinte

Postcode

93420

Country

France

Scientific contact point

Organisation

Guerbet

Contact name

Sophie Rollin

Public contact point

Organisation

Guerbet

Contact name

Frantz Hébert

Third parties 1

Bracco Imaging S.p.A.

Sponsor organisation

Bracco Imaging S.p.A.

Address

Via Egidio Folli 50

City

Milan

Postcode

20134

Country

Italy

Scientific contact point

Organisation

Bracco Imaging S.p.A.

Contact name

Gianpaolo Pirovano

Public contact point

Organisation

Bracco Imaging S.p.A.

Contact name

Gianpaolo Pirovano

Sponsor responsibilities

Article 77 compliance

Guerbet

Contact point sponsor

Guerbet

Article 77 implementation

Guerbet

Locations

7 EU/EEA countries · 29 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 49 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications