[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553147":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":48,"collaborators":24,"id":50,"slug":24,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":24,"enrollmentInfo":58,"targetDuration":24,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":24,"overallStatus":68,"whyStopped":24,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stage I","EXPERIMENTAL","Five patients with HNSCC will undergo a dynamic \\[18F\\]-olaparib PET during 30 min, followed by a static whole body PET scans at 120 min post-injection of \\[18F\\]-olaparib.",[13],"Diagnostic Test: [18F]-olaparib PET scan",{"label":15,"type":10,"description":16,"interventionNames":17},"Stage II","After determination of the most optimal time point for imaging, five patients with HNSCC scheduled for chemoradiotherapy will undergo serial \\[18F\\]-olaparib PET at baseline (i.e. prior to treatment initiation) and a second scan during the first week of chemoradiotherapy. Patients in stage II will undergo a study biopsy in the first week of chemoradiotherapy to evaluate changes in PARP protein expression.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","[18F]-olaparib PET scan","The IMP investigated is \\[18F\\]Olaparib, a radiolabelled PARP inhibitor suitable for PET imaging.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Michel van Kruchten, MD, PhD","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":24,"email":33},"CONTACT","+31 50 361 2821","m.van.kruchten@umcg.nl",[35],{"facility":5,"status":24,"city":36,"state":24,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Groningen","9713 GZ","Netherlands",{"type":40,"coordinates":41},"Point",[42,43],6.56667,53.21917,{"lat":43,"lon":42},[46,47],{"name":27,"role":31,"phone":32,"phoneExt":24,"email":33},{"name":27,"role":28,"phone":24,"phoneExt":24,"email":24},{"type":49,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100553147",false,"NCT06482307","Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET","[18F]-olaparib","Inclusion Criteria:\n\n1. Patients \\>18y, with biopsy-proven HPV-negative HNSCC, or patients \\>40y with HPV-positive HNSCC and high-risk features (i.e. \\> 10 smoke packs\u002Fyear AND ≥N2b)\n2. Treatment with chemoradiotherapy using platinum-based chemotherapy is anticipated\n3. Recent archival tumour tissue (\\\u003C8 weeks prior to inclusion) should be available with suffi-cient residual material for determination of tumour PARP1 levels\n4. Presence of a tumour lesion ≥10 mm in diameter\n5. ECOG performance status 0-2\n6. Negative pregnancy test in women with childbearing potential\n7. Life expectancy \\>3 months\n8. Signed written informed consent and able to comply with the protocol\n9. For stage II only: re-biopsy should be deemed feasible by the investigators (assessed by head-and-neck surgeon)\n\nExclusion Criteria:\n\n1. Recent treatment with PARP inhibitors or other investigational therapies \\\u003C30 days.\n2. Presence of significant co-morbidities that make participation in the study undesirable according to the treating physician.","ALL","18 Years",{"count":59,"type":60},10,"ESTIMATED","INTERVENTIONAL",[63,64],"PHASE1","PHASE2","This is a single-centre, non-randomized, two-stage design, proof-of-concept study evaluating the radiolabelled PARP inhibitor \\[18F\\]-olaparib als potential tracer for imaging of tumour PARP expression by PET.",[67],"Head and Neck Squamous Cell Carcinoma (HNSCC)","NOT_YET_RECRUITING","2025-04-15",{"date":71,"type":72},"2025-04-18","ACTUAL",{"date":74,"type":60},"2025-05",{"date":76,"type":60},"2026-02",{"name":5,"class":6},1]