Alexander Nikanorov

Lisa Lim

Craig Bonsignore

Paul Bishop

Lindsay Pack

Prasanna Hariharan

Aldo Badano

Marilou Bastan (works at CCF with Dr. Timur Sarac)

Achim Zipse

Donna Lochner

 

Introductory Comments

 

Tech Transfer Agreements – FDA is drafting

–        Decided to go with individual CDAs for different organizations that want to see proprietary data

–        MTA:  collective for those who want access to data early

 

Projected Cost of Study – Funding Possibilities

–        Estimate (from Vik):

o       Per patient cost (clinical trial only):  $13, 084

o       Per patient with indirect costs:  $20, 149 (federally funded would be higher than industry funded, not sure what number Vik gave us)

o       Database and imaging analysis: will be more (table until we figure this out): 

§         Minimum: ? (Paul will figure this out)

§         Estimated range:  ? (Paul will figure this out)

§         Database (Laurie Vivian):  flat rate (won’t be a per patient rate)

–        120 pts in IVUS study (recalling n=30 for extra imaging)

–        ACTION (Request from VIK to ASPECT): 

o       Modeling method

§         CCF Modelers: do they have time, help us with cost estimates, writing of grant application

o       Specific equipment that Vik will need to get into proper CT wedge configuration

§         Alexander:  agreed to finance (suggest that Vik develop with his engineers & radiology techs); will need one for open CT system, one for rotational CT system – they are the best ones to know what will fit in his radiology equipment

§         ACTION:  Paul will try to find out if there is someone from CCF BMEs who could work on this, will give Alexander a name

 

Imaging System Characterization – If not phantom, then ?

–        Phantom costs/complexity:  Craig hasn’t done phantom studies in the past, and got good data

–        Using stent in study:   look at macro dimensions (strut lengths, widths etc.) in the imaging systems and compare to micrometer measurements

–        IVUS/CT:  stent on table or in bucket of water

–        Expose at 37°C and then image at 25°C – dimensions shouldn’t change (Bard confirmed that this should work for the Bard stent)

–        ACTION:  Paul – let Achim know what stents he’d like

–        ALDO:  agree that this will be all you need as long as you can measure at the resolution you need for the modeling

o       IDEAL:  use CT to measure the stent b/c CT might have some limits in the measurement of small stent features, so that you can ensure that your model is representative of what you are measuring

o       Include a scale with your image

o       Calipers to measure stent on the table, and confirm with dataset from images

o       Images for IVUS, X-Ray and CT (since all will be used for model)

o       Paul:  can image IVUS at both RT and 37°C; image CT & X-Ray at RT only

 

Outstanding ACTION Items

• Tech Transfer contact information forms – complete and send to Lisa
• Everyone on this call has informed Lisa of their status (remind group members that they will be considered non-confidential and this will change their permissions on the web-site)
• Set up meeting with CCF Modeling Group – Paul
• CCF participation will affect submission of a grant, so a quick meeting would be helpful (before 12/2, if possible)

 

 

Next Meeting:  12/02/09 (No meeting on 11/25/09)