Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose (LEADER 75)

Bayer

Status and phase: Completed; Phase 4

Conditions: Magnetic Resonance Imaging

Treatments: Drug: Gadoterate (Dotarem/Clariscan); Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03602339

19773

2018-000690-78 (EudraCT Number)

Details and patient eligibility

About

The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is applied to improve the analysability of MRI-images.

The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.

Full description

The study was an open-label, multi-center, comparative, cross-over trial in adult patients with known or highly suspected CNS pathology who were referred for imaging of the CNS.

The primary objective of the study was to demonstrate the non-inferiority of gadobutrol (0.075 mmol/ kg body weight) to gadoterate (0.1 mmol/ kg body weight).

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Known or highly suspected central nervous system (CNS) pathology referred for contrast-enhanced MRI of the CNS.
• Glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m2 derived from a serum creatinine result within four weeks prior to the first study MRI.
• Women with negative urine pregnancy test within 1 hour prior to the administration of gadoterate (the first MRI).

Exclusion criteria

• No enhancing lesion visible on the gadoterate-enhanced MRI scan.
• Pregnancy or breastfeeding.
• Severe cardiovascular disease

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

157 participants in 2 patient groups

Arm 1_Suspected CNS-lesion

Experimental group

Description:

Patients with suspected or confirmed CNS-lesions underwent unenhanced MRI, and contrast-enhanced MRI after gadoterate injection.

Treatment:

Drug: Gadoterate (Dotarem/Clariscan)

Arm 2_Confirmed CNS-lesion

Experimental group

Description:

Patients with gadoterate-confirmed CNS-lesions (subgroup of Arm 1) underwent a second unenhanced MRI, and contrast-enhanced MRI after gadobutrol injection.

Treatment:

Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)

Drug: Gadoterate (Dotarem/Clariscan)