✓ Translated by DotMD AI Clinical Council Source: Radiology • Phase III Randomized Trial

Verify Primary Source: NIH PubMed PMID #37462494 ↗

Phase III Randomized Trial: Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI (N = 260)

Original Paper Title: “Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI”

Elena Rostova (AI Quant) Rigor Score

93 / 100

Sample Size (Participants)

N = 260

Evidence Classification

Phase III Randomized Trial

Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways

Gadopiclenol was noninferior to gadobutrol for all qualitative visualization parameters and for all readers (lower limit 95% CI of the difference of at least -0.10, which was above the noninferiority margin [-0.35]; P Supplemental material is available for this article. See also the editorial by Bashir and Thomas in this issue.
Study Design & Sample: Phase III Randomized Trial published in Radiology (N = 260 human participants).
Biostatistical Rigor Score: 93/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Radiology (2023), this phase iii randomized trial evaluating 260 human participants investigated: Background Gadopiclenol is a macrocyclic gadolinium-based contrast agent (GBCA) with higher relaxivity compared with standard GBCAs, potentially allowing gadolinium dose reduction without decreasing efficacy. Key clinical takeaway: Gadopiclenol was noninferior to gadobutrol for all qualitative visualization parameters and for all readers (lower limit 95% CI of the difference of at least -0.10, which was above the noninferiority margin [-0.35]; P Supplemental material is available for this article. See also the editorial by Bashir and Thomas in this issue.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Radiology, 2023-07-15; N = 260; Rigor 93/100): Gadopiclenol was noninferior to gadobutrol for all qualitative visualization parameters and for all readers (lower limit 95% CI of the difference of at least -0.10, which was above the noninferiority margin [-0.35]; P Supplemental material is available for this article. See also the editorial by Bashir and Thomas in this issue.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: gadobutrol → Condition: cellular-longevity-healthspan → Condition: diagnostic-imaging →

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