[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620410":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":53,"collaborators":12,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":12,"enrollmentInfo":64,"targetDuration":12,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":38,"whyStopped":12,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group (A)","NO_INTERVENTION","Participants will undergo the conventional \\[⁶⁸Ga\\]Ga-PSMA PET\u002FCT protocol, which includes a standard whole-body PET\u002FCT performed 60 minutes post-injection and a delayed pelvic PET\u002FCT as per current clinical practice (PET + CT).",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention Group (B)","EXPERIMENTAL","Participants will undergo:\n\n* Standard whole-body PET\u002FCT at 60 minutes, followed by\n* A delayed pelvic PET-only acquisition at 90 minutes, reconstructed using the CT obtained during the initial whole-body acquisition.",[18],"Diagnostic Test: Intervention Group",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DIAGNOSTIC_TEST","Intervention Group","Matching of delayed PET images with the standard CT scan",[14],[26],{"name":27,"affiliation":28,"role":29},"Michela Moscarino, Technician","IRCCS Università di Bologna, Policlinico di Sant'Orsola","PRINCIPAL_INVESTIGATOR",[31],{"name":27,"role":32,"phone":33,"phoneExt":12,"email":34},"CONTACT","+390512143179","michela.moscarino@aosp.bo.it",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":40,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"IRCCS - Policlinico Universitario di Sant'Orsola","RECRUITING","Bologna","Italy","40138","IT",{"type":44,"coordinates":45},"Point",[46,47],11.33875,44.49381,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":12,"email":34},"Michela Moscarino","Technician",{"type":29,"investigatorFullName":51,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Principal Investigator","100620410","delayed-pelvic-imaging-with-68ga-psma-petct-in-a-patient-with-high-risk-prostate-cancer-100620410",false,"NCT07357259","Delayed Pelvic Imaging With [68]Ga-PSMA PET\u002FCT in a Patient With High-risk Prostate Cancer.","SPIR202302","Inclusion Criteria:\n\n* Newly diagnosed prostate cancer undergoing staging, or\n* Biochemical recurrence following prior radical-intent therapy (surgery and\u002For radiotherapy), or\n* High-risk prostate cancer, defined as Gleason Score ≥ 8 or PSA ≥ 20 ng\u002FmL.\n* Written informed consent and authorization for personal data processing.\n\nExclusion Criteria:\n\n* Genitourinary comorbidities that could interfere with imaging or interpretation.\n* Intermediate- or low-risk prostate cancer.\n* Delayed acquisition performed on a PET\u002FCT scanner different from the standard acquisition.\n* Additional PET\u002FCT required due to artifacts compromising diagnostic quality (e.g., urinary retention, excessive motion).\n* Patients previously enrolled who require repeat PET\u002FCT as a new visit.\n* Inability to provide informed consent or impaired decision-making capacity.\n* Known hypersensitivity to the radiopharmaceutical or its components.\n* Contraindications to PET\u002FCT (e.g., severe claustrophobia, morbid obesity, inability to cooperate).","MALE","30 Years",{"count":65,"type":66},244,"ESTIMATED","INTERVENTIONAL",[69],"NA","Recent evidence suggests that both standard-time and delayed-time \\[⁶⁸Ga\\]Ga-PSMA PET acquisitions can reveal clinically relevant findings, and neither phase should be excluded a priori in routine practice. This study evaluates a streamlined dual-phase protocol consisting of:\n\n* A standard whole-body PET\u002FCT acquisition performed 60 minutes after radiotracer administration.\n* A delayed pelvic PET-only acquisition performed 90 minutes post-injection, reconstructed using the attenuation-correction CT (CT\u002FAC) obtained from the initial whole-body scan.\n\nBecause the prostate gland and pelvic lymph nodes exhibit minimal physiological mobility, accurate PET-CT anatomical correspondence can be maintained through careful patient repositioning, without repeating the CT scan.\n\nThe main advantage of this protocol is a reduction in patient radiation exposure, as the delayed phase does not require a second CT scan. It also reduces in-department time and maintains diagnostic quality of PET interpretation, provided that the PET-CT alignment remains acceptable.\n\nThis method may additionally enhance workflow efficiency in the Nuclear Medicine Unit by allowing early identification-based on predefined clinical parameters-of patients most likely to benefit from delayed pelvic imaging.",[72],"High-risk Prostate Cancer",[74,75,76,77],"PET\u002FCT","[68]Ga - PSMA","Delay CT scan","Radiation Dose Optimization","2026-01-12",{"date":80,"type":81},"2026-01-21","ACTUAL",{"date":83,"type":81},"2025-02-03",{"date":85,"type":66},"2027-03-01",{"name":5,"class":6},1]