Consensus recommendations for hyperpolarized [1-¹³C]pyruvate MRI multi-center human studies.

Area of Science:

• Medical Imaging
• Biophysics
• Metabolic Research

Background:

• Hyperpolarized (HP) [1-¹³C]pyruvate MRI enables in vivo assessment of cellular metabolism.
• This technique has been translated to human studies across various diseases at multiple international centers.

Purpose of the Study:

• To establish consensus on best practices for conducting multi-center human studies using HP [1-¹³C]pyruvate MRI.
• To guide the development and standardization of clinical applications for this imaging modality.

Main Methods:

• A two-round formal consensus-building exercise involving 29 experts from 13 sites.
• Experts represented pharmacy methods, MR physics, translational imaging, and data analysis.
• 246 statements covering preparation, system setup, acquisition, reconstruction, and data analysis were evaluated.

Main Results:

• Consensus was achieved on approximately two-thirds of the statements across all evaluated categories.
• Key agreements include standardized release criteria for HP pyruvate preparation and phantom-based quality assurance for site qualification.
• Preferences were noted for specific pulse sequences and reconstruction methods based on anatomical targets, and for normalized metabolite area-under-curve values as preferred metrics.

Conclusions:

• HP [1-¹³C]pyruvate MRI technology is sufficiently mature for planning multi-center studies.
• The consensus process identified areas of agreement for multi-center study conduct and highlighted areas needing further research to ascertain optimal best practices.