Deliverables
A first workshop and international conference will be organized to create the demand for the NICI stratification. By doing so, the NICI consortium will train current and future health care professionals. It will focus on education for undergraduate-students, PhDs and post-doctoral fellows. In addition, sessions will be organised for clinical staff. A report will be submitted providing the set-up of the programme and attendees list.
First design on new imaging characteristicsReport on the first design of the imaging strategies and breathinggated multinuclear imaging
Report on normalisation procedureCAM will incorporate pre-scan data from all receivers to normalize for patient induced field non-uniformities and simultaneously to maximize sensitivity. The report will describe how the normalisation has been established.
Prediction modelThe metabolic alterations from the four anticipated subtypes of metastases in the FOLFOX treatment that relate best to organoid survival will be selected D13 as the scan protocol Threshold levels will be based on cluster analyses incorporating in vivo baselines D43This report will give a description of the prediction model and a guideline on how the model can be used
Report on baseline chemistry levels in liver of healthy volunteersIn all four sites at least 5 healthy volunteers will be scanned as defined in D33 From these subjects the corresponding metabolite levels will be assessed in the healthy liver These levels included their spatial and subject variance will be reported
Report on effective spin excitation in the human body on all nuclei at the three MRI sitesThe B1+ level that can be obtained in a phantom that mimics a patient load, must be determined for all 3 sites at all 5 nuclei. The levels will be used to finetune the MRI sequences and set in scan software as maximum B1+ per nuclei.
Document specifying limits across setups and corresponding settings for safe usageConsidering the safety limits as determined in D21 and the B1 levels in D24 for all 3 systems the fixed hardware parameters will be defined such that all systems can match the conditions for scanning with identical boundary conditions ie the lowest max B1 between the 3 sites is used and the most conservative safety setting between the three sites
Report on data processing and interpretationSoftware and procedures to quantify the metabolic imaging data will be finalized. This in line with the levels as reported in D4.3
Updated report on Quality controlAn updated report on quality control will be written by AMC
Trial management planA detailed planning and trial setup and submission package for ethical approval will be prepared for the accrual of 3 times 5 healthy subjects as well as 150 patients with metastasised colon cancer in Pisa 50 Amsterdam 50 and Cambridge 50 taking into account gender balance Based on our CAIRO2 CAPOXB treatment arm data and given a uniform accrual of 150 colorectal cancer patients over a time course of 1 year with a minimum followup of two treatment cycles ie 29 weeks and with a maximum of 6 FOLFOX cycles we expect 65 cases to end in progression within the timespan of the project
Safety margin files for using the quintuple body resonator with and without meta-materialsA spin out result from the MCUBE (FET Open 2016) includes the use of META-materials (UMCU is involved). This data is compared to traditional bodycoil designs for efficiency and safety. Numerical simulations will be obtained and local SAR for all 5 frequencies will be calculated and compared. The document will be used to make decision on final design, and the values used in scanner software to assure safe scanning.
Report on validation of prediction modelCAM will verify chemistry data with the predefined model to match treatment outcome AMC will consider dynamic approaches such as Bayesian Markov chain Monte Carlo joint longitudinalsurvival models These models will contain many metabolic features ie phospholipid and lactate metabolism diffusion permeability and chemical exchange simultaneously to derive a dynamic metabolic signature predictive of percycle treatment outcome
Report on chemical imaging pulse sequence, including a list of pulse sequences to image physiologyDemonstrate CSI scans for all nuclei including the more standard imaging as defined in D31 In addition incorporate editing techniques that optimize the detection of the most discriminative metabolic markers as defined by D13
Report on imaging strategyDefine for all three systems the 1H imaging strategy for obtaining relevant anatomy and physiology scans of the liver. These include DWI, CEST, T2-weighted MRI, and DCE-MRI. Spatial resolutions, echo-times, TR, scantimes have to be defined and standard over all platforms.
Established cross-vendor DICOM standard for chemistry imaging dataA standard for data storage for the chemistry data needs to be defined and validated for the data from all three vendors. The data needs to have functionalities similar as the standard DICOM used for all medical imaging modalities, such that it can be stored in any hospital archive. The level of preprocessing needs to be clarified and defined as standard.
List of groups and stakeholders for targeted disseminationTo actively approach groups and stakeholders for preparing the dissemination of results from the NICO project, a full list will be compiled and completed by the members of NICI.
Report on further exploration NICI applicationsThe report will present the results of scans of healthy and cancerous tongue lung and pancreas as well as cardiac scans of healthy volunteers
NICI website and logoA logo will be designed. The NICI website will be setup highlighting the EU logo, collaborators, tutorials and present preliminary results. A report will be written, containing screen shots and URL of the website and logo.
NICI organoid culture bank with 90 organoidsAMC will deliver 3 samples from 30 patients (patientderived oesophageal and pancreatic cancer organoids from an existing organoid culture bank covering the entire spectrum of tumour heterogeneity) to prof Burgering (UMCU). A report will be written on the establishment of the organoid culture bank.
Report on Quality controlA report on quality control and safety is given with regards to the trial An update is foreseen to be given at the end of the project D55 The following tasks will be checked and implementedo Appointment of NICI Clinical Trial Manager NICI Data Manager and local Clinical Study TeamsoStart of study preparation by ICI Clinical Trial Manager NICI Data Manager and local Clinical Study TeamsoStudy documents information sheets and informed consent forms prepared and internally approvedoStudy protocols finalisedoprocedure for international monitoring finalisedoEthical approval granted for study and monitoring protocol at all clinical sitesoNICI Data collection and processing infrastructure ready for useoAll clinical sites fully equipped and ready to start patient inclusionReport on quality controloFirst Patient or study subject First Visit FPFVoLast Patient or study subject First Visit LPFVoLast Patient or study subject Last Visit for primary analysis LPLVoPrimary end of Study EXCLUDING followup and data analysis note in case of positive endpoint participated institutes are entitles to incorporate more patients using alternative sources of funding
Final dissemination and Exploitation planA final dissemination and exploitation plan will be written with the TTOs at the academic partners and industry partners Exploitation of the NICI stratification will be explored
Definite scan protocol for predicting chemotherapy efficacyBased on the results of D32 define a fixed scan protocol list identical for all 3 systems that maximizes the chance of predicting treatment efficacy within a scan time that is tolerable by the patients 45 minutes
Second workshop, training module and international conferenceA second workshop training module and international conference will be organized to create the demand for the NICI stratification By doing so the NICI consortium will train current and future health care professionals It will focus on education for undergraduatestudents PhDs and postdoctoral fellows In addition sessions will be organised for clinical staff A report will be submitted providing the setup of the programme and attendees list
Quintuple tuned body resonators and detectors installed at Pisa, Amsterdam and CambridgeThe designs of D2.2 are constructed and interfaced to the 3 MRI systems. The designs are composed of a triple tunable bodycoil integrated in the MRI, where the patient bore gets exchanged, or when RF shield is too close, where a thin layer bodycoil is inserted in the existing tube. The other two frequencies are based on dipole transceiver arrays positioned in a flexible housing around the patient. In these housings another array of triple tuned receivers will be implemented based on the maximum number of channels available on the MRI system (up to a maximum of 32). Siemens, Philips and GE will provide the interface description for connecting the RF coils, the patient tubes as well as the RF amplifiers that drive the bodycoil.
Setup an open access data management system that protects patients anonymity while enabling storage of traceable imaging data as well as the organoid NMR data
Publications
Author(s):
van den Wildenberg L, Gursan A, Seelen LWF, van der Velden TA, Gosselink MWJM, Froeling M, van der Kemp WJM, Klomp DWJ, Prompers JJ.
Published in:
NMR in Biomedicine, 2022, ISSN 0952-3480
Publisher:
John Wiley & Sons Inc.
DOI:
10.1002/nbm.4877
Author(s):
Ria Forner, Kyungmin Nam, Klijs J. de Koning, Tijl van der Velden, Wybe van der Kemp, Alexander Raaijmakers and Dennis W. J. Klomp
Published in:
Frontiers in Neurology, Issue 16642295, 2021, ISSN 1664-2295
Publisher:
Frontiers Research Foundation
DOI:
10.3389/fneur.2021.695202
Author(s):
Aline Xavier, Catalina Arteaga de Castro, Marcelo E. Andia, Peter R. Luijten, Dennis W. Klomp, Ariane Fillmer, Jeanine J. Prompers
Published in:
NMR in Biomedicine, Issue 33/8, 2020, ISSN 0952-3480
Publisher:
John Wiley & Sons Inc.
DOI:
10.1002/nbm.4343
Author(s):
S. Brinkhof, A. Ali Haghnejad, K. Ito, K. Markenroth Bloch, D.W.J. Klomp
Published in:
NMR in Biomedicine, Issue 32/11, 2019, ISSN 0952-3480
Publisher:
John Wiley & Sons Inc.
DOI:
10.1002/nbm.4173
Author(s):
Q. Houtum, F.A.A. Mohamed Hoesein, J.J.C. Verhoeff, P.S.N. Rossum, A.S.R. Lindert, T.A. Velden, W.J.M. Kemp, D.W.J. Klomp, C.S. Arteaga de Castro
Published in:
NMR in Biomedicine, 2019, ISSN 0952-3480
Publisher:
John Wiley & Sons Inc.
DOI:
10.1002/nbm.4204
Author(s):
de Graaf RA, Hendriks AD, Klomp DWJ, Kumaragamage C, Welting D, Arteaga de Castro CS, Brown PB, McIntyre S, Nixon TW, Prompers JJ, De Feyter HM.
Published in:
NMR in Biomedicine, 2020, Page(s) 1-9, ISSN 0952-3480
Publisher:
John Wiley & Sons Inc.
DOI:
10.1002/nbm.4235
Author(s):
Wybe J. M. van der Kemp; Maria T. Grinde; Jon O. Malvik; Hanneke W. M. van Laarhoven; Jeanine J. Prompers; Dennis W. J. Klomp; Boudewijn Burgering; Tone Frost Bathen; Siver Andreas Moestue
Published in:
ISSN=0952-3480;TITLE=NMR in Biomedicine, Issue 1, 2023, Page(s) 1-11, ISSN 0952-3480
Publisher:
John Wiley & Sons Inc.
DOI:
10.1002/nbm.4882
Author(s):
Seelen LWF, van den Wildenberg L, van der Kemp WJM, Mohamed Hoesein FAA, Mohammad NH, Molenaar IQ, van Santvoort HC, Prompers JJ, Klomp DWJ
Published in:
Journal of Magnetic Resonance Imaging, 2022, ISSN 1053-1807
Publisher:
John Wiley & Sons Inc.
DOI:
10.1002/jmri.28372
Author(s):
Q. Houtum, D. Welting, W.J.M. Gosselink, D.W.J. Klomp, C.S. Arteaga de Castro, W.J.M. Kemp
Published in:
NMR in Biomedicine, Issue 32/12, 2019, ISSN 0952-3480
Publisher:
John Wiley & Sons Inc.
DOI:
10.1002/nbm.4178
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