Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-03 @ 7:07 PM
Study NCT ID:
NCT01918592
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2013-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET/MRI and Biomarkers in Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2013-08-05', 'studyFirstSubmitQcDate': '2013-08-07', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Accuracy of prognostic biomarkers to estimate response to neoadjuvant chemotherapy.', 'timeFrame': '6 mo', 'description': 'Accuracy of tissue, blood and urine based biomarkers to estimate response to neoadjuvant chemotherapy is estimated'}], 'primaryOutcomes': [{'measure': 'staging accuracy of PET/MRI in bladder cancer', 'timeFrame': '3 months', 'description': 'Accuracy of PET/MRI to stage newly diagnosed bladder cancer. MRI/PET staging results is compared to pathology report of TUR-BT and cystectomy specimens.'}], 'secondaryOutcomes': [{'measure': 'Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy', 'timeFrame': '3 mo', 'description': 'Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy prior to radical cystectomy. MRI/PET results is compared to pathology report of cystectomy specimen.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bladder cancer', 'neoadjuvant chemotherapy', 'radical cystectomy', 'lymphadenectomy', 'biomarker'], 'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '30068379', 'type': 'DERIVED', 'citation': 'Salminen A, Jambor I, Merisaari H, Ettala O, Virtanen J, Koskinen I, Veskimae E, Sairanen J, Taimen P, Kemppainen J, Minn H, Bostrom PJ. 11C-acetate PET/MRI in bladder cancer staging and treatment response evaluation to neoadjuvant chemotherapy: a prospective multicenter study (ACEBIB trial). Cancer Imaging. 2018 Aug 2;18(1):25. doi: 10.1186/s40644-018-0158-4.'}]}, 'descriptionModule': {'briefSummary': 'Muscle invasive bladder cancer is an aggressive malignancy. Currently the investigators lack accurate imaging technologies in clinical staging and estimation of response to neoadjuvant chemotherapy as well as prognostic biomarkers.\n\nIn the current study novel imaging modality (MRI/PET) is utilized to stage bladder cancer prior to transurethral resection of bladder-tumor and after neoadjuvant chemotherapy. Also prognostic biomarkers are studied from TUR-BT tissues, blood and urine to estimate response to neoadjuvant chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* invasive or locally advanced bladder cancer based on cystoscopic evaluation\n* Age: 18 to 85 years old\n* Language spoken: Finnish or Swedish\n* Mental status: Patients must be able to understand the meaning of the study\n* Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff\n\nExclusion Criteria:\n\n* Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease\n* Infections: Patient must not have an uncontrolled serious infection\n* Contraindications for MRI (cardiac pacemaker, intracranial clips etc)\n* Patient refusing radical cystectomy or chemotherapy\n* Intravesical Bacillus Calmette-Guerin instillations within 6 months'}, 'identificationModule': {'nctId': 'NCT01918592', 'acronym': 'ACEBIB', 'briefTitle': 'PET/MRI and Biomarkers in Bladder Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'PET/MRI and Biomarkers in Clinical Staging of Bladder Cancer and in the Estimation of Neoadjuvant Chemotherapy Response Prior to Radical Cystectomy', 'orgStudyIdInfo': {'id': 'ACEBIB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI/PET', 'interventionNames': ['Device: MRI/acetate-PET imaging']}], 'interventions': [{'name': 'MRI/acetate-PET imaging', 'type': 'DEVICE', 'otherNames': ['Philips Ingenuity PET/MR device', '11C-acetate as PET-tracer'], 'armGroupLabels': ['MRI/PET']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20100', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief, department of urology', 'investigatorFullName': 'Peter Boström', 'investigatorAffiliation': 'Turku University Hospital'}}}}