Recruiting
Phase 3

Gadopiclenol vs. Gadoterate Meglumine

Sponsor:

Guerbet

Code:

NCT07348640

Conditions

Steno-occlusive Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

gadopiclenol

Gadoterate meglumine (Dotarem)

Study Details

Brief summary:

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

Conditions

Steno-occlusive Disease

Study ID

NCT07348640

Start date

Jul 28, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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:

1. 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
2. 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
3. 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:

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.

Study Design

Enrollment

315 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: AB

Gadopiclenol administered first followed by Gadoterate meglumine 0.1 mmol/kg

active comparator: BA

Gadoterate meglumine 0.1 mmol/kg administered first followed by Gadopiclenol

Interventions

gadopiclenol

Gadopiclenol enhanced-Magnetic Resonance Angiography

Gadoterate meglumine (Dotarem)

Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography

Primary outcome measure

  • Non-inferiority [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Northshore - Evanston Hospital

Recruiting

Evanston, Illinois, United States, 60201

More Information

Sponsor

Guerbet

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Keywords

  • steno-occlusive disease
  • gadopiclenol
  • Magnetic Resonnance Angiography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Guerbet on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.