TOPIC : Non-invasive clinical molecular imaging of immune cells
|Publication date:||15 March 2018|
|Types of action:||IMI2-RIA Research and Innovation action|
|DeadlineModel: Opening date:||two-stage 15 March 2018||Deadline: 2nd stage Deadline:||
14 June 2018 17:00:00
11 December 2018 17:00:00
|Time Zone : (Brussels time)|
Topic DescriptionSpecific Challenge:
For full details of the topic, please refer to the call text
Current pharmacodynamic (PD) assessments of immune cells are based on peripheral blood biomarkers, or from biopsy samples which are acquired by invasive procedures. Some existing medical imaging modalities provide a quantifiable, non-invasive, repeatable and localised measure of biological processes in the living body. However, current methodology and technology provides limited information on time-dependent and disease-specific relevant immune cell subpopulations and compartments types, or measures of direct engagement of immune targets.
Imaging tracers designed to bind specific immune cells (‘immunotracers’) or targets within immune-mediated pathways would enable the clinical imaging of the target immune cell subtypes and immune markers of disease in a clinical setting, which in turn would provide in vivo insights into effects of immunomodulatory therapies at disease sites (organs/tissues) and improve knowledge about the pathophysiology of various immune-mediated diseases.
Molecular imaging agents, (hybrid) imaging modalities, and image processing algorithms to image immune cells in vivo are advancing within the imaging field and can provide an immediate, non-invasive read-out of target expression over time. However, further novel imaging agents and technologies will need to be developed in order to extend the applicability of immune cell imaging to additional disease areas, additional tissue sites, and/or immune cell subpopulations especially by increasing the specificity of imaging agents. Therefore, there remains a need to better understand the currently available markers and validate them extensively for clinical use.Scope:
For full details of the topic, please refer to the call text
This topic aims to establish a consortium that can develop and validate a quantitative, non-invasive, immune cell imaging platform, which includes novel and target-specific molecular imaging agents, (hybrid) imaging modalities, and image processing algorithms. The topic aligns with the IMI2 Strategic Research Agenda, as it aims to validate immune cell targets based on human biology and to facilitate precision medicine by identification and stratification of patients and prediction of therapeutic outcomes. In addition, it is expected that these agents will facilitate early diagnosis of the disease and/or classification of disease based on the immune phenotype.Expected Impact:
For full details of the topic, please refer to the call text.
Molecular imaging of immune cells could provide an early indicator of whether patients are likely to benefit from a given (immuno-) therapeutic intervention (surrogate of response). The technology to be delivered is expected to have the potential to also provide information for tissue/organ sites that are not biopsy-accessible, thus representing a significant advance in the assessment of the immune marker status for the relevant indications. Patients can be stratified by marker expression, with the potential to offer the most appropriate treatment and thereby reduce the implementation of treatment regimens that are unlikely to be efficacious and would therefore have a negative benefit-risk profile for the individual patient (personalised
By visualising and quantifying the impact of therapy on specific target sites and related immune-mediated pathways, the planned technology is also expected to reduce ambiguity in the evaluation of efficacy during clinical trials (e.g. provide early indications of patient responses, assessment of variability between and within individuals, facilitate proof of mechanism (POM) and proof of concept (POC) studies of new mechanisms). Spatio-temporal complexity can be studied due to longitudinal imaging capabilities.
Furthermore, it will have significant impact on personalised approaches to detect and better monitor these diseases already in the early and better treatable stages. It will support and guide physicians and patients in determining the most appropriate care, leading to improved efficiency in the health care system and patient benefits. It is envisioned that the topic will ultimately result in the regulatory acceptance of standardised protocols with validated immune-imaging approaches. Consequently, those approaches will significantly reduce the time and cost of clinical trials.
Small and medium-sized enterprises (SMEs) can be of great benefit to IMI2 JU projects. Their involvement in the action might offer a complementary perspective to industry and academia, and help deliver the long-term impact of the project.
Topic conditions and documents
Please read carefully all provisions below before the preparation of your application.
The IMI2 JU 14th Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information :
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.
Signature of grant agreements: maximum 3 months from the date of informing successful applicants.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):
Proposal templates are available after entering the submission tool
Standard evaluation form
Clinical trial template – the Clinical Trial template is compulsory at stage 2 only !
6. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the H2020 main Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
7. Additional documents:
LEARs, Account Administrators or self-registrants can publish partner requests for open and forthcoming topics after logging into the Participant Portal.
To access the Electronic Submission Service of the topic, please select the type of action that is most relevant to your proposal from the list below and click on the 'Start Submission' button. You will then be asked to confirm your choice of the type of action and topic, as these cannot be changed in the submission system. Upon confirmation you will be linked to the correct entry point.
To access existing draft proposals for this topic, please login to the Participant Portal and select the My Proposals page of the My Area section.
|Type of Action||Research and Innovation action [IMI2-RIA]|
|Topic||Non-invasive clinical molecular imaging of immune cells - IMI2-2018-14-02|
|Guidance on proposal submission:||H2020 online manual|
H2020 Online Manual is your guide on the procedures from proposal submission to managing your grant.
Participant Portal FAQ – Submission of proposals.
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