Transcript presentation WP1 Vienna March 2011

WP1 Progress report
Vienna, 13 March 2011
Achievements
General
- 4 Staff members (1 Image Analyst, 1 part-time Radiologist, 2
Research Assistants) in place
- Obtained approval from Medicines and Healthcare products
Regulatory Agency
- Local Ethical Approval obtained provisionally, pending
clarifications
Achievements
Structural Imaging
1
2
3
4
1
2
3
Site survey ✔
Site selection ✔
Radiological and structural protocols (ADNI-GO) for 3T scanners
finalised and Manual sent to sites ✔
Image Management System (TrialTracker) and electronic data
transfer tool (TrialWire) ✔
Sites to upload protocol and return protocol form in progress
Sites to scan phantom and send details to IXICO in progress
Sites to scan 1 healthy volunteer and send details to IXICO not
started
Qualification and start scanning
Achievements
Structural Imaging
3T SITE
London
Prague
Leuven
Utrecht
Melbourne
Copenhagen
Tel Aviv
Madrid
Naples
Bucharest
Survey Survey Protocol
Sent Received
Sent
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Protocol ACR Phantom ACR Phantom ACR Phantom
Received
at Site
Scan Requested Scan Received
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
N
Y
Y
Y
N
Y
Y
Y
N
Y
Y
Y
N
Y
N
N
N
N
N
N
N
N
N
N
N
Innsbruck considering to join WP1
Achievements
Magnetic Resonance Spectroscopy
1
2
3
4
London, Copenhagen, Utrecht have met and agreed protocol
Spectra (anterior cingulate and thalamus) from Copenhagen
and Utrecht can be read and give reasonable values
The data can provide metabolite ratios
Currently exploring whether we can do correction for CSF in
the MRS voxel which is a superior approach to the ratio
method
Milestones
1 Completion of preparation work for MRI sites
2 Start scanning
Deliverables
1 Qualification of sites, test of electronic data transfer tool
2 Estimate of numbers (200 in total: if 10 sites, 20 patients per
site)
Possible concerns
Combination of MRS data:
- Existing power calculation did not take into account the
greater variability of multicentre design
- Increase number of subjects with MRS at each site (~30-40
each: existing plan is for 20 subjects scanned twice in London
and Copenhagen, so it would be slightly more than double)
- If datasets cannot be combined, we could explore whether
findings are reproduced across sites
Planned progress
-
Obtain final approval from local ethics
Qualify sites
Start recruitment and scanning
All sites to continue to scan phantom regularly plus 2 healthy
volunteers (from the site) yearly, preferably every 6 months
and before and after upgrades