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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

ConditionSteno-occlusive Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuerbet

About this trial

Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal / renal arteries using MRI

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

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

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

Disqualifiers

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.

Has any known allergy to one or more of the ingredients in the investigational products or has a history of hypersensitivity to other GBCAs.

Trial design

Design model

Crossover

Treatments tested in this trial

  • gadopiclenol

    Drug

    Gadopiclenol enhanced-Magnetic Resonance Angiography

  • Gadoterate meglumine (Dotarem)

    Drug

    Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography

Treatment groups

315 Participants
are divided into 2 treatment groups
Group A: ABExperimental treatment 2 interventions
Group B: BAActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Non-inferiority

To demonstrate the non-inferiority of gadopiclenol-enhanced Magnetic Resonance Angiography (MRA) 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.

Time frame
30 days

Secondary outcomes

1

Adverse Events

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

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guerbet

Lead sponsor

Bracco Imaging S.p.A.

Collaborator

Source ClinicalTrials.gov
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