Contributions
Abstract: EP1533
Type: ePoster
Abstract Category: Therapy - disease modifying - Tools for detecting therapeutic response
Background: Brain Volume Loss (BVL) in Multiple Sclerosis (MS) is an outcome for neuroprotective properties of treatment in clinical trials. Efforts to translate individualized BVL monitoring into clinical care are ongoing.
Goal: We present technical and logistical limitations associated with the implementation of BVL tools in clinical practice, based on BraVo pilot project.
Methods: BraVo pilot project is a Canadian collaborative project involving 11 MS neurologists from 6 MS Clinics. It aims to assess usefulness of BVL measurements in individualized patient and suitability of clinical MRI protocol for BVL analysis. Each neurologist chose 10 subjects with at least 3 MRIs. BVL analysis is performed centrally by UBC MS/MRI group. Clinical usefulness and barriers to the implementation of BVL tools will be assessed by surveying the clinicians involved.
Results: MRI analysis is ongoing for 51 subjects. 210 MRIs were analysed for BVL. Study initiation was delayed on average by 8 months (range 5-13) mainly by ethics approval in each site. Data Transfer Agreement (DTA) was mandatory for 4 sites and is still pending for 1 site (16 months). After de-identification, three different ways were used for MRI transfer: burned DVD (2 sites), web portal (2) and secure cloud storage (1).
Technical limitations were tracked on a 10-point scoring system based on recent MS MRI protocol recommendations from the Consortium of MS Clinics. Sequences used (3DT1, PD, T2, FLAIR), longitudinal consistency, spatial resolution, absence of slice gap, whole-head coverage, artifacts and RFI (Radio Frequency Inhomogeneity) were looked at. On average, a score of 7 was given (1-8). Insufficient spatial resolution (86%), lack of longitudinal consistency (36%) and RFI (72%) more frequently contributed to lower scores. Specific recommendations will be provided to each site, in order to make their MS MRI protocol more suitable for BVL analysis.
Conclusion: Clinical usefulness of Brain Volume monitoring in individual patients will greatly depend on reliability of Brain Volume measurements. Delays associated with ethics and data transfer can limit the applicability of a centralized service of Brain Volume assessments. On the analysis side, BVL tools still require technical expertise. Consistent MRI data quality remains the biggest challenge for implementation of BVL to individualized patient care. Recommendations for a standardized MS imaging protocol need to be followed.
Disclosure:
Philippe Beauchemin: Consulting fees: Novartis, EMD Serono.
Robert Carruthers: Grants/Research Support: Site PI for studies funded by MedImmune, Teva and Guthy Jackson; Speakers Bureau/Honoraria: Speaking fees for unbranded lectures from Biogen, Genzyme and Teva; Consulting Fees: Novartis, EMD Serono, Genzyme.
Roger Tam: nothing to disclose.
Andrew Riddehough: nothing to disclose.
David Li: has received research funding from the Canadian Institute of Health Research and Multiple Sclerosis Society of Canada. He is the Director of the UBC MS/MRI Research Group which has been contracted to perform central analysis of MRI scans for therapeutic trials with Novartis, Perceptives, Roche and Sanofi-Aventis. The UBC MS/MRI Research Group has also received grant support for investigator-initiated independent studies from Genzyme, Merck-Serono, Novartis and Roche. He has acted as a consultant to Vertex Pharmaceuticals and served on the Data and Safety Advisory Board for Opexa Therapeutics and Scientific Advisory Boards for Adelphi Group, Novartis and Roche. He has also given lectures which have been supported by non-restricted education grants from Novartis and Biogen.
Anthony Traboulsee: is a consultant for Novartis, Genzyme, Roche and a principal investigator on clinical trials with Biogen, Genzyme, Roche, and Chugai.
BraVo pilot project was funded by Novartis Canada Inc.
Abstract: EP1533
Type: ePoster
Abstract Category: Therapy - disease modifying - Tools for detecting therapeutic response
Background: Brain Volume Loss (BVL) in Multiple Sclerosis (MS) is an outcome for neuroprotective properties of treatment in clinical trials. Efforts to translate individualized BVL monitoring into clinical care are ongoing.
Goal: We present technical and logistical limitations associated with the implementation of BVL tools in clinical practice, based on BraVo pilot project.
Methods: BraVo pilot project is a Canadian collaborative project involving 11 MS neurologists from 6 MS Clinics. It aims to assess usefulness of BVL measurements in individualized patient and suitability of clinical MRI protocol for BVL analysis. Each neurologist chose 10 subjects with at least 3 MRIs. BVL analysis is performed centrally by UBC MS/MRI group. Clinical usefulness and barriers to the implementation of BVL tools will be assessed by surveying the clinicians involved.
Results: MRI analysis is ongoing for 51 subjects. 210 MRIs were analysed for BVL. Study initiation was delayed on average by 8 months (range 5-13) mainly by ethics approval in each site. Data Transfer Agreement (DTA) was mandatory for 4 sites and is still pending for 1 site (16 months). After de-identification, three different ways were used for MRI transfer: burned DVD (2 sites), web portal (2) and secure cloud storage (1).
Technical limitations were tracked on a 10-point scoring system based on recent MS MRI protocol recommendations from the Consortium of MS Clinics. Sequences used (3DT1, PD, T2, FLAIR), longitudinal consistency, spatial resolution, absence of slice gap, whole-head coverage, artifacts and RFI (Radio Frequency Inhomogeneity) were looked at. On average, a score of 7 was given (1-8). Insufficient spatial resolution (86%), lack of longitudinal consistency (36%) and RFI (72%) more frequently contributed to lower scores. Specific recommendations will be provided to each site, in order to make their MS MRI protocol more suitable for BVL analysis.
Conclusion: Clinical usefulness of Brain Volume monitoring in individual patients will greatly depend on reliability of Brain Volume measurements. Delays associated with ethics and data transfer can limit the applicability of a centralized service of Brain Volume assessments. On the analysis side, BVL tools still require technical expertise. Consistent MRI data quality remains the biggest challenge for implementation of BVL to individualized patient care. Recommendations for a standardized MS imaging protocol need to be followed.
Disclosure:
Philippe Beauchemin: Consulting fees: Novartis, EMD Serono.
Robert Carruthers: Grants/Research Support: Site PI for studies funded by MedImmune, Teva and Guthy Jackson; Speakers Bureau/Honoraria: Speaking fees for unbranded lectures from Biogen, Genzyme and Teva; Consulting Fees: Novartis, EMD Serono, Genzyme.
Roger Tam: nothing to disclose.
Andrew Riddehough: nothing to disclose.
David Li: has received research funding from the Canadian Institute of Health Research and Multiple Sclerosis Society of Canada. He is the Director of the UBC MS/MRI Research Group which has been contracted to perform central analysis of MRI scans for therapeutic trials with Novartis, Perceptives, Roche and Sanofi-Aventis. The UBC MS/MRI Research Group has also received grant support for investigator-initiated independent studies from Genzyme, Merck-Serono, Novartis and Roche. He has acted as a consultant to Vertex Pharmaceuticals and served on the Data and Safety Advisory Board for Opexa Therapeutics and Scientific Advisory Boards for Adelphi Group, Novartis and Roche. He has also given lectures which have been supported by non-restricted education grants from Novartis and Biogen.
Anthony Traboulsee: is a consultant for Novartis, Genzyme, Roche and a principal investigator on clinical trials with Biogen, Genzyme, Roche, and Chugai.
BraVo pilot project was funded by Novartis Canada Inc.