CTSC:multicenter101410

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Agenda

1. establishment of the first virtual trial

Multicenter Clinical Trail Working group Meeting Minutes October 14, 2010

In attendance:

• Valerie Humblet
• Bob Lenkinski
• Clare Tempany
• Charles Guttmann
• Simon Warfield

MRI neuroimaging virtual trial

• It will be done with 3T MRI scanners, without contrast, with a multi-element head coil. Three sequences will be run: T2 weighted, FLAIR and MP RAGE. We will implement a common protocol with human phantoms.
• The dataset will be transfer on a server (HIPPA compliant) and we will look for reproducibility for 3 outcome measures; total brain volume, CFS and white vs gray matter.
• The goal is to understand where protocols are equivalent and different. Need to understand intra- and inter- variability. We will also test the differences obtained with different versions of same software.
• We will also do a pediatric version of the trial:
  • Phantoms: we need phantoms appropriate for the age of the child. It is very difficult to scan human phantoms for pediatric studies.
  • 2 protocols are needed, one for young children and one for teenager (for example at age 10, the FLAIR sequence needs new settings)

Extension to other disease and modalities

• We can offer recommendation on the best phantoms for a specific disease. We also offer advices on calibration of theses phantoms.
• Important questions: How often do we do the scanning, how many volunteer does one need to be relevant, what about gender (it is best to cover age and gender but it will depend on the disease).
• Validation: there must be a consensus between segmentation, Staple is a good tool to provide for validation.

Next steps

• Implement a virtual PET trial
• Look at ACRIN for example son multi-center CT trials (ex: liver, colonography: Daniel Jonhson)
• Standardization of dose measurement
• Talk about IRB issues
• Think about funding mechanism