{"id":9648,"date":"2024-02-13T16:12:42","date_gmt":"2024-02-13T15:12:42","guid":{"rendered":"https:\/\/www.icta.fr\/?post_type=casclients&p=9648"},"modified":"2026-01-14T10:23:47","modified_gmt":"2026-01-14T09:23:47","slug":"a-prospective-study-on-an-imp-pet-ct-imaging-in-biochemical-recurrence-of-prostate-cancer","status":"publish","type":"casclients","link":"https:\/\/www.icta.fr\/fr\/cas-clients\/a-prospective-study-on-an-imp-pet-ct-imaging-in-biochemical-recurrence-of-prostate-cancer\/","title":{"rendered":"A Prospective study on an IMP PET\/CT Imaging in Biochemical Recurrence of Prostate Cancer"},"content":{"rendered":"\n
<\/div>
\n

OBJECTIVES<\/h3>\n\n\n\n
\n
\n

PRIMARY OBJECTIVE<\/h4>\n\n\n\n

<\/p>\n\n\n\n

    \n
  • Compare Per-patient detection rate of 18F-IMP PET\/CT versus that of 18F-FCH PET\/CT<\/li>\n<\/ul>\n<\/div>\n\n\n\n
    \n

    SECONDARY OBJECTIVES<\/h4>\n\n\n\n

    <\/p>\n\n\n\n

      \n
    • Comparison of the per-region detection rate<\/li>\n\n\n\n
    • Comparison of the sensitivity and specificity<\/li>\n\n\n\n
    • Concordance rate on a region basis<\/li>\n\n\n\n
    • Comparison of the impact on patient treatment\/management<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
      \n
      \n

      SCIENTIFIC and DATA vALORISATION<\/h3>\n\n\n\n
        \n
      • Submission of marketing authorization application for [18F]-IMP to the European Medicines Agency (EMA)<\/li>\n\n\n\n
      • Client obtained marketing authorisation from EMA<\/li>\n\n\n\n
      • Support provided during the writing by the client of lead article from the trial results<\/li>\n\n\n\n
      • Overall excellent client satisfaction<\/li>\n<\/ul>\n<\/div>\n\n\n\n
        \n

        Key factors of success<\/strong><\/h3>\n\n\n\n
          \n
        • ICTA\u2019s expertise in methodology and IT Tools development<\/li>\n\n\n\n
        • ICTA\u2019s capability to propose innovative solutions for unusual projects<\/li>\n\n\n\n
        • ICTA\u2019s responsiveness and and capacity to mobilize ICTA’s expertise and skills <\/em><\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
          \n
          \n

          LESSONS LEARNED to speed up the start-up phase of the next study<\/h3>\n\n\n\n
            \n
          • The importance of close cooperation between ICTA and Sponsor and regular communication, specifically in the early stage of the project and at time of CSR writing in order to define and respond to the sponsor expectations and needs<\/li>\n\n\n\n
          • ICTA possess a competent staff within various domains of expertise capable of  working together in order to quickly and efficiently development of the necessary tool to fulfil the sponsor needs<\/li>\n\n\n\n
          • Optimal project coordination: Timelines, logistics, sub-contractors management, reporting tools implementation, event management.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n

            CHALLENGES<\/h3>\n\n\n\n
            KEY CHALLENGES<\/th>ICTA’s SOLUTIONS<\/th>ICTA’s ACHIEVEMENTS<\/th><\/tr><\/thead>
            Sites selection and patient recruitment<\/strong>
            Multicenter study carried out in several European countries

            <\/td>            		ICTA\u2019s longstanding partners in European countries mandated for:
            . Regulatory submissions
            . Sites management
            in 4 European countries: France, Belgium, Spain, The Netherland<\/strong>.
            <\/td>            		\u00b7  40 sites identified
            \u00b7  25 sites selected
            \u00b7  22 active sites
            \u25b6 100%<\/strong> of sites included at least one patient


            <\/td><\/tr>
            Deadline due to EMA submission<\/strong>
            \u00b7  Increase follow-up period






            <\/td>            		. Close follow-up of site
            . Close collaboration with the Sponsor who is actively involved with site coordination
            . Risk management plan
            . Kick off meeting for CSR writing and close collaboration with the Sponsor to be on time
            . Additional data analyses\/ release to support Sponsor answer to EMA.
            <\/td>            		. CSR was delivered on due date.
            . Supportive analyses data provided in due time to support Sponsor response during EMA, marketing authorisation review process.






            <\/td><\/tr>
            Truth panel management<\/strong>



            <\/td>            		. Quick development of a new online tool to allow data remote evaluation by expert and eCRF data exchange.


            <\/td>            		. Mobilization of ClinOps, Data management and IT departments allow to add a new IT tool and more session of the truth panel without changing the study timelines.
            Data quality ensured<\/strong>
            <\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div><\/section>\n\n\n\n
              \n
            • <\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":15,"featured_media":10785,"template":"","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","inline_featured_image":false,"_uag_custom_page_level_css":"","kk_blocks_editor_width":"","_kiokenblocks_attr":"","_kiokenblocks_dimensions":"","footnotes":""},"categories":[],"class_list":["post-9648","casclients","type-casclients","status-publish","has-post-thumbnail","hentry"],"acf":[],"uagb_featured_image_src":{"full":["https:\/\/www.icta.fr\/wp-content\/uploads\/petct-scaled.jpg",2560,1280,false],"thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/petct-128x88.jpg",128,88,true],"medium":["https:\/\/www.icta.fr\/wp-content\/uploads\/petct-300x150.jpg",300,150,true],"medium_large":["https:\/\/www.icta.fr\/wp-content\/uploads\/petct-768x384.jpg",768,384,true],"large":["https:\/\/www.icta.fr\/wp-content\/uploads\/petct-1024x512.jpg",1024,512,true],"1536x1536":["https:\/\/www.icta.fr\/wp-content\/uploads\/petct-1536x768.jpg",1536,768,true],"2048x2048":["https:\/\/www.icta.fr\/wp-content\/uploads\/petct-2048x1024.jpg",2048,1024,true],"post-thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/petct-1568x784.jpg",1568,784,true],"wpm_taille_1":["https:\/\/www.icta.fr\/wp-content\/uploads\/petct-364x257.jpg",364,257,true],"wpm_taille_slider":["https:\/\/www.icta.fr\/wp-content\/uploads\/petct-240x145.jpg",240,145,true],"gform-image-choice-sm":["https:\/\/www.icta.fr\/wp-content\/uploads\/petct-scaled.jpg",300,150,false],"gform-image-choice-md":["https:\/\/www.icta.fr\/wp-content\/uploads\/petct-scaled.jpg",400,200,false],"gform-image-choice-lg":["https:\/\/www.icta.fr\/wp-content\/uploads\/petct-scaled.jpg",600,300,false]},"uagb_author_info":{"display_name":"Manon ROBERT","author_link":"https:\/\/www.icta.fr\/fr\/author\/mrobert-icta21\/"},"uagb_comment_info":0,"uagb_excerpt":null,"_links":{"self":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/9648","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients"}],"about":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/types\/casclients"}],"author":[{"embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/users\/15"}],"version-history":[{"count":8,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/9648\/revisions"}],"predecessor-version":[{"id":9673,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/9648\/revisions\/9673"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/media\/10785"}],"wp:attachment":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/media?parent=9648"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/categories?post=9648"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}