Gadopiclenol Maintains Image Quality at a Reduced Gadolinium Dose for Intracranial Vessel and Aneurysm Wall MRI

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Unruptured intracranial aneurysms (n=53). Intervention: Gadopiclenol (0.05 mmol/kg) vs. Gadobutrol (0.1 mmol/kg). Primary outcome: Aneurysm wall enhancement percentage (EP) (p=1.00 (adjusted); p=0.71 in mixed-effects model).

Q: What does this research mean for the field?

Half-dose gadopiclenol (0.05 mmol/kg) provides comparable image quality and vessel wall enhancement metrics to standard-dose gadobutrol (0.1 mmol/kg) in intracranial vessel wall MRI. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

Ramona‐Alexandra Todea; Jordan M Villiers; Moisés Felipe Molina-Fuentes; Aggeliki Apostolou; Nicolin Hainc; Zsolt Kulcsár

doi:10.21203/rs.3.rs-11387884/v1

November 5, 2026Open Access

Gadopiclenol Maintains Image Quality at a Reduced Gadolinium Dose for Intracranial Vessel and Aneurysm Wall MRI

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Key result

Half-dose gadopiclenol matches full-dose gadobutrol for intracranial aneurysm wall enhancement and image quality.

P=1.00 (adjusted); p=0.71 in mixed-effects model
n=53

Why the study?

Intracranial vessel wall MRI relies on gadolinium-based contrast agents, and gadopiclenol is a high-relaxivity agent that may provide comparable diagnostic performance at half the gadolinium dose of conventional agents. This study was conducted to compare the contrast enhancement performance of half-dose gadopiclenol with standard-dose gadobutrol.

Does half-dose gadopiclenol (0.05 mmol/kg) maintain comparable image quality and contrast enhancement metrics compared to standard-dose gadobutrol (0.1 mmol/kg) in patients with unruptured cerebral aneurysms undergoing intracranial vessel wall MRI?

Key Points

To compare the contrast enhancement performance and image quality of half-dose gadopiclenol with standard-dose gadobutrol for intracranial vessel wall MRI.
Retrospective single-center study of 53 patients with cerebral aneurysms undergoing vessel wall MRI using either gadopiclenol (0.05 mmol/kg, n = 26) or gadobutrol (0.1 mmol/kg, n = 27) on Siemens and Philips 3-T scanners.
Qualitative image quality was independently evaluated using four-point Likert scales, and quantitative metrics (enhancement percentage, lesion-to-background ratio, aneurysm-to-noise ratio, normalized signal intensity) were analyzed using Wilcoxon rank-sum tests and mixed-effects models.
No statistically significant differences were observed between gadopiclenol and gadobutrol for any qualitative or quantitative metric after Bonferroni correction.
Non-significant trends included improved border delineation with gadobutrol (adjusted p = 0.094) and higher lesion-to-background ratio with gadopiclenol (adjusted p = 0.073), with mixed-effects models confirming no agent effect on enhancement percentage (p = 0.71) or normalized signal intensity (p = 0.34).
Inter-reader agreement was very good to excellent for qualitative assessment (kappa = 0.601–0.947) and good to excellent for aneurysm-specific quantitative metrics (ICC = 0.673–0.805).

Study Design

Type

Observational (n=53)

Multicenter

No

Structured PICO

Does half-dose gadopiclenol (0.05 mmol/kg) maintain comparable image quality and contrast enhancement metrics compared to standard-dose gadobutrol (0.1 mmol/kg) in patients with unruptured cerebral aneurysms undergoing intracranial vessel wall MRI?

P

Population

53 adults (median age 61 years, IQR 49-70) with untreated unruptured cerebral aneurysms undergoing follow-up 3-T intracranial vessel wall MRI between June 2024 and May 2025.

E

Exposure

Half-dose gadopiclenol (0.05 mmol/kg; 0.5 mol solution, 0.1 mL/kg) administered for 3 T intracranial vessel wall MRI (n=26)

C

Comparator

Standard-dose gadobutrol (0.1 mmol/kg; 1.0 mol solution, 0.1 mL/kg) administered to a sample-size matched control group for the same indication on the same 3 T MRI scanner systems (n=27)

O

Outcome

Qualitative image quality (overall image quality, subjective image noise, border delineation, and vessel or aneurysm wall morphology rated on 4-point Likert scales) and quantitative contrast enhancement metrics (enhancement percentage [EP], lesion-to-background ratio [LBR], aneurysm-to-noise ratio [ANR], and normalized signal intensity [SI]) of the internal carotid artery, vertebral artery, and aneurysm wallsurrogate

Main Result

Absolute Event Rate: 29.6% vs 23.81%

p-value: p=1.00 (adjusted); p=0.71 in mixed-effects model

Half-dose gadopiclenol (0.05 mmol/kg) provides qualitative image quality and quantitative vessel and aneurysm wall enhancement comparable to standard-dose gadobutrol (0.1 mmol/kg), supporting reduced gadolinium dosing in patients undergoing serial intracranial vessel wall MRI.

Limitations

Retrospective single-center study design
Relatively small sample size (n=53) limiting statistical power and generalizability
Vessel wall enhancement assessment was limited to the intradural internal carotid arteries and V4 segments of the vertebral arteries
Examinations were acquired across two different 3-T MRI vendor platforms
Poor inter-reader agreement for background-dependent metrics (lesion-to-background ratio and aneurysm-to-noise ratio)
Relatively small sample size limiting statistical power and generalizability
Assessment of vessel wall enhancement was limited to the intradural internal carotid arteries and V4 segments of the vertebral arteries
Examinations were performed on two different MRI vendor platforms, contributing to potential scanner-related variability

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Implication

Supports half-dose gadopiclenol to limit gadolinium exposure in aneurysm imaging; leaves open prospective validation before clinical adoption.

Abstract

Background Intracranial vessel wall MRI (VW-MRI) relies on gadolinium-based contrast agents (GBCAs) to assess cerebrovascular pathologies. Gadopiclenol is a high-relaxivity GBCA that may provide comparable diagnostic performance at half the gadolinium dose of conventional agents. This study compares the contrast enhancement performance of gadopiclenol with standard-dose gadobutrol for intracranial VW-MRI. Methods In this retrospective single-center study, patients with cerebral aneurysms underwent VW-MRI using either gadopiclenol (0.05 mmol/kg) or gadobutrol (0.1 mmol/kg). Qualitative image quality was independently assessed using four-point Likert scales for overall image quality, subjective noise, border delineation, and vessel wall morphology. Quantitative analyses included enhancement percentage (EP), lesion-to-background ratio (LBR), aneurysm-to-noise ratio (ANR), and normalized signal intensity (SI). Group comparisons used Wilcoxon rank-sum tests with Bonferroni correction. Mixed-effects models accounted for repeated measures and scanner variability. Inter-reader agreement was assessed using ICC and weighted Cohen's κ. Results Baseline characteristics were comparable between groups for all 53 patients and no statistically significant differences were observed between gadopiclenol (n = 26) and gadobutrol (n = 27) groups for any qualitative or quantitative metric after Bonferroni correction. A trend toward improved border delineation with gadobutrol (adjusted p = 0.094) and higher LBR with gadopiclenol (adjusted p = 0.073) did not reach statistical significance. Mixed-effects models confirmed no significant contrast-agent effect on EP ( p = 0.71) or normalized SI ( p = 0.34). Inter-reader agreement was excellent for qualitative image assessment (κ = 0.601–0.947) and good to excellent for aneurysm-specific quantitative metrics (ICC = 0.673–0.805), while background-dependent metrics demonstrated lower reproducibility. Conclusions Half-dose gadopiclenol provided image quality and enhancement metrics comparable to standard-dose gadobutrol, supporting its use for intracranial vessel wall MRI while reducing gadolinium exposure.

Discussion

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Cite This Study

Todea et al. (2026) conducted an observational in Unruptured intracranial aneurysms (n=53). Gadopiclenol (0.05 mmol/kg) vs. Gadobutrol (0.1 mmol/kg) was evaluated on Aneurysm wall enhancement percentage (EP) (p=1.00 (adjusted); p=0.71 in mixed-effects model). Half-dose gadopiclenol (0.05 mmol/kg) provided comparable aneurysm wall enhancement percentage (29.6% vs 23.81%, adjusted p=1.00) and image quality to full-dose gadobutrol (0.1 mmol/kg).

synapsesocial.com/papers/6aee6be671a7594806220c90 https://doi.org/10.21203/rs.3.rs-11387884/v1

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Gadopiclenol Maintains Image Quality at a Reduced Gadolinium Dose for Intracranial Vessel and Aneurysm Wall MRI

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Gadopiclenol Maintains Image Quality at a Reduced Gadolinium Dose for Intracranial Vessel and Aneurysm Wall MRI

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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