Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT05318612
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2022-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of MR-guided LITT Therapy in Irresectable Glioblastoma (EMITT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, multicenter, open-label randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 238}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2022-03-23', 'studyFirstSubmitQcDate': '2022-04-01', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Depending on which event occurs first: either when a study participant dies or at the end of the trial (61 months).', 'description': 'Percentage of patients still alive for a given period of time after randomization.'}, {'measure': 'Health Related Quality of Life (HR-QoL)', 'timeFrame': 'At 5 months after randomization', 'description': 'QoL measured with the QLQ-C30BN20 at 5 months after randomization.'}], 'secondaryOutcomes': [{'measure': 'Costs', 'timeFrame': 'At 1, 2, 3, 4, 5, 6, 12, 18, 30, 42 and 54 months after randomization.', 'description': 'Use of care and health-related costs measured using costs questionnaires.'}, {'measure': 'Ablation rate', 'timeFrame': 'Using the MRI made right after LITT procedure', 'description': 'Measuring the expected ablation rate.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'During the entire study period, estimated 18 months for each patient', 'description': 'The length of time during and after the treatment of the disease that a patient lives with the disease but it does not get worse.'}, {'measure': 'Disease Specific Survival (DSS)', 'timeFrame': 'During the entire study period, estimated 18 months for each patient', 'description': 'The percentage of patients who have not died from glioblastoma.'}, {'measure': 'Complication rate', 'timeFrame': 'During the entire study period, estimated 18 months for each patient', 'description': 'Registration of complications in both study groups.'}, {'measure': 'Overall survival since intervention', 'timeFrame': 'During the entire study period, estimated 18 months for each patient', 'description': 'Percentage of patients still alive for a given period of time after surgery.'}, {'measure': 'Tumor volume response', 'timeFrame': 'Using the MRI made right after LITT procedure', 'description': 'Response of tumor tissue to LITT.'}, {'measure': 'Effects of LITT on adjuvant treatment', 'timeFrame': 'During the entire study period, estimated 18 months for each patient', 'description': 'Effects of LITT on the effect of adjuvant treatment assessed by tumor response to chemotherapy and radiotherapy on follow-up MRI.'}, {'measure': 'General Quality of Life', 'timeFrame': 'At randomization, 72 hours after surgery, 1, 2, 3, 4, 5, 6, 12, 18, 30, 42 and 54 months after randomization.', 'description': 'QoL measured with the QoL questionnaires.'}, {'measure': 'Longitudinal effects', 'timeFrame': 'During the entire study period, estimated 18 months for each patient.', 'description': 'Changes attributable to aging during the study period. Longitudinal effects will be assessed using mixed model analysis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Glioblastoma']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Incidentie Hersentumoren. IKNL. https://www.iknl.nl/kankersoorten/hersentumoren/registratie/incidentie. Accessed October 7, 2020.'}, {'pmid': '25559415', 'type': 'BACKGROUND', 'citation': 'Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.'}, {'pmid': '26459813', 'type': 'BACKGROUND', 'citation': 'Rouse C, Gittleman H, Ostrom QT, Kruchko C, Barnholtz-Sloan JS. Years of potential life lost for brain and CNS tumors relative to other cancers in adults in the United States, 2010. Neuro Oncol. 2016 Jan;18(1):70-7. doi: 10.1093/neuonc/nov249. Epub 2015 Oct 12.'}, {'pmid': '15758009', 'type': 'BACKGROUND', 'citation': 'Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.'}, {'pmid': '25079102', 'type': 'BACKGROUND', 'citation': 'Weller M, van den Bent M, Hopkins K, Tonn JC, Stupp R, Falini A, Cohen-Jonathan-Moyal E, Frappaz D, Henriksson R, Balana C, Chinot O, Ram Z, Reifenberger G, Soffietti R, Wick W; European Association for Neuro-Oncology (EANO) Task Force on Malignant Glioma. EANO guideline for the diagnosis and treatment of anaplastic gliomas and glioblastoma. Lancet Oncol. 2014 Aug;15(9):e395-403. doi: 10.1016/S1470-2045(14)70011-7.'}, {'pmid': '27310651', 'type': 'BACKGROUND', 'citation': 'Brown TJ, Brennan MC, Li M, Church EW, Brandmeir NJ, Rakszawski KL, Patel AS, Rizk EB, Suki D, Sawaya R, Glantz M. Association of the Extent of Resection With Survival in Glioblastoma: A Systematic Review and Meta-analysis. JAMA Oncol. 2016 Nov 1;2(11):1460-1469. doi: 10.1001/jamaoncol.2016.1373.'}, {'pmid': '31236819', 'type': 'BACKGROUND', 'citation': 'De Witt Hamer PC, Ho VKY, Zwinderman AH, Ackermans L, Ardon H, Boomstra S, Bouwknegt W, van den Brink WA, Dirven CM, van der Gaag NA, van der Veer O, Idema AJS, Kloet A, Koopmans J, Ter Laan M, Verstegen MJT, Wagemakers M, Robe PAJT; Quality Registry Neuro Surgery glioblastoma working group from the Dutch Society of Neurosurgery. Between-hospital variation in mortality and survival after glioblastoma surgery in the Dutch Quality Registry for Neuro Surgery. J Neurooncol. 2019 Sep;144(2):313-323. doi: 10.1007/s11060-019-03229-5. Epub 2019 Jun 24.'}, {'pmid': '29295569', 'type': 'BACKGROUND', 'citation': 'Haj A, Doenitz C, Schebesch KM, Ehrensberger D, Hau P, Putnik K, Riemenschneider MJ, Wendl C, Gerken M, Pukrop T, Brawanski A, Proescholdt MA. Extent of Resection in Newly Diagnosed Glioblastoma: Impact of a Specialized Neuro-Oncology Care Center. Brain Sci. 2017 Dec 25;8(1):5. doi: 10.3390/brainsci8010005.'}, {'pmid': '29410102', 'type': 'BACKGROUND', 'citation': 'Ashraf O, Patel NV, Hanft S, Danish SF. Laser-Induced Thermal Therapy in Neuro-Oncology: A Review. World Neurosurg. 2018 Apr;112:166-177. doi: 10.1016/j.wneu.2018.01.123. Epub 2018 Feb 2.'}, {'pmid': '33477796', 'type': 'BACKGROUND', 'citation': 'Viozzi I, Guberinic A, Overduin CG, Rovers MM, Ter Laan M. Laser Interstitial Thermal Therapy in Patients with Newly Diagnosed Glioblastoma: A Systematic Review. J Clin Med. 2021 Jan 19;10(2):355. doi: 10.3390/jcm10020355.'}, {'pmid': '31449372', 'type': 'BACKGROUND', 'citation': 'Williams D, Loshak H. Laser Interstitial Thermal Therapy for Epilepsy and/or Brain Tumours: A Review of Clinical Effectiveness and Cost-Effectiveness [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Jun 17. Available from http://www.ncbi.nlm.nih.gov/books/NBK545597/'}, {'pmid': '33293629', 'type': 'BACKGROUND', 'citation': 'Weller M, van den Bent M, Preusser M, Le Rhun E, Tonn JC, Minniti G, Bendszus M, Balana C, Chinot O, Dirven L, French P, Hegi ME, Jakola AS, Platten M, Roth P, Ruda R, Short S, Smits M, Taphoorn MJB, von Deimling A, Westphal M, Soffietti R, Reifenberger G, Wick W. EANO guidelines on the diagnosis and treatment of diffuse gliomas of adulthood. Nat Rev Clin Oncol. 2021 Mar;18(3):170-186. doi: 10.1038/s41571-020-00447-z. Epub 2020 Dec 8.'}, {'pmid': '21324954', 'type': 'BACKGROUND', 'citation': 'Maringwa J, Quinten C, King M, Ringash J, Osoba D, Coens C, Martinelli F, Reeve BB, Gotay C, Greimel E, Flechtner H, Cleeland CS, Schmucker-Von Koch J, Weis J, Van Den Bent MJ, Stupp R, Taphoorn MJ, Bottomley A; EORTC PROBE Project and Brain Cancer Group. Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients. Ann Oncol. 2011 Sep;22(9):2107-2112. doi: 10.1093/annonc/mdq726. Epub 2011 Feb 15.'}, {'pmid': '16321761', 'type': 'BACKGROUND', 'citation': 'Taphoorn MJ, Stupp R, Coens C, Osoba D, Kortmann R, van den Bent MJ, Mason W, Mirimanoff RO, Baumert BG, Eisenhauer E, Forsyth P, Bottomley A; European Organisation for Research and Treatment of Cancer Brain Tumour Group; EORTC Radiotherapy Group; National Cancer Institute of Canada Clinical Trials Group. Health-related quality of life in patients with glioblastoma: a randomised controlled trial. Lancet Oncol. 2005 Dec;6(12):937-44. doi: 10.1016/S1470-2045(05)70432-0.'}, {'pmid': '17999840', 'type': 'BACKGROUND', 'citation': 'Garside R, Pitt M, Anderson R, Rogers G, Dyer M, Mealing S, Somerville M, Price A, Stein K. The effectiveness and cost-effectiveness of carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma: a systematic review and economic evaluation. Health Technol Assess. 2007 Nov;11(45):iii-iv, ix-221. doi: 10.3310/hta11450.'}, {'pmid': '26113069', 'type': 'BACKGROUND', 'citation': 'Medvid R, Ruiz A, Komotar RJ, Jagid JR, Ivan ME, Quencer RM, Desai MB. Current Applications of MRI-Guided Laser Interstitial Thermal Therapy in the Treatment of Brain Neoplasms and Epilepsy: A Radiologic and Neurosurgical Overview. AJNR Am J Neuroradiol. 2015 Nov;36(11):1998-2006. doi: 10.3174/ajnr.A4362. Epub 2015 Jun 25.'}, {'pmid': '11145211', 'type': 'BACKGROUND', 'citation': 'McDannold NJ, Jolesz FA. Magnetic resonance image-guided thermal ablations. Top Magn Reson Imaging. 2000 Jun;11(3):191-202. doi: 10.1097/00002142-200006000-00005.'}, {'pmid': '26910903', 'type': 'BACKGROUND', 'citation': 'Leuthardt EC, Duan C, Kim MJ, Campian JL, Kim AH, Miller-Thomas MM, Shimony JS, Tran DD. Hyperthermic Laser Ablation of Recurrent Glioblastoma Leads to Temporary Disruption of the Peritumoral Blood Brain Barrier. PLoS One. 2016 Feb 24;11(2):e0148613. doi: 10.1371/journal.pone.0148613. eCollection 2016.'}, {'pmid': '24810945', 'type': 'BACKGROUND', 'citation': 'Mohammadi AM, Hawasli AH, Rodriguez A, Schroeder JL, Laxton AW, Elson P, Tatter SB, Barnett GH, Leuthardt EC. The role of laser interstitial thermal therapy in enhancing progression-free survival of difficult-to-access high-grade gliomas: a multicenter study. Cancer Med. 2014 Aug;3(4):971-9. doi: 10.1002/cam4.266. 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Clin Plast Surg. 2016 Jul;43(3):505-13. doi: 10.1016/j.cps.2016.03.007.'}, {'pmid': '34156076', 'type': 'BACKGROUND', 'citation': 'Di L, Wang CP, Shah AH, Eichberg DG, Semonche AM, Sanjurjo AD, Luther EM, Jermakowicz WJ, Komotar RJ, Ivan ME. A Cohort Study on Prognostic Factors for Laser Interstitial Thermal Therapy Success in Newly Diagnosed Glioblastoma. Neurosurgery. 2021 Aug 16;89(3):496-503. doi: 10.1093/neuros/nyab193.'}, {'pmid': '25580512', 'type': 'BACKGROUND', 'citation': 'Patel NV, Jethwa PR, Shetty A, Danish SF. Does the real-time thermal damage estimate allow for estimation of tumor control after MRI-guided laser-induced thermal therapy? Initial experience with recurrent intracranial ependymomas. J Neurosurg Pediatr. 2015 Apr;15(4):363-71. doi: 10.3171/2014.10.PEDS13698. Epub 2015 Jan 16.'}, {'pmid': '7529367', 'type': 'BACKGROUND', 'citation': 'Nakagawa M, Matsumoto K, Higashi H, Furuta T, Ohmoto T. Acute effects of interstitial hyperthermia on normal monkey brain--magnetic resonance imaging appearance and effects on blood-brain barrier. Neurol Med Chir (Tokyo). 1994 Oct;34(10):668-75. doi: 10.2176/nmc.34.668.'}, {'pmid': '18219673', 'type': 'BACKGROUND', 'citation': 'Rieke V, Butts Pauly K. MR thermometry. J Magn Reson Imaging. 2008 Feb;27(2):376-90. doi: 10.1002/jmri.21265.'}, {'pmid': '37612610', 'type': 'DERIVED', 'citation': 'Neutel CLG, Viozzi I, Overduin CG, Rijpma A, Grutters JPC, Hannink G, van Eijsden P, Robe PA, Rovers MM, Ter Laan M. Study protocol for a multicenter randomised controlled trial on the (cost)effectiveness of biopsy combined with same-session MR-guided LITT versus biopsy alone in patients with primary irresectable glioblastoma (EMITT trial). BMC Cancer. 2023 Aug 23;23(1):788. doi: 10.1186/s12885-023-11282-7.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the (cost-)effectiveness of LITT (Laser Interstitial Thermal Therapy) in primary irresectable glioblastoma. Glioblastoma are the most common malignant brain tumors and are, due to their devastating nature and the fact that these tumors occur at a relatively young age (median 59 years), responsible for up to 7% of total life years lost from cancer before the age of 70.\n\nThe current treatment of glioblastoma consists of maximal safe surgery combined with adjuvant chemoradiation therapy (CRT). However, despite this aggressive treatment, these patients still face a poor prognosis (median overall survival 14.5 - 18.5 months). In addition to that, around 30% of the patients diagnosed with a glioblastoma are not suitable for surgery. These patients miss the benefit of a resection and face an even worse prognosis (median overall survival 5.1 months).\n\nThe primary aim of this project is to investigate whether laser therapy combined with CRT improves overall survival, without compromising quality of life, in comparison with CRT alone in patients with primary irresectable glioblastoma.', 'detailedDescription': 'RATIONALE: Glioblastoma (GBM) is the most common primary brain tumor with about 1000 new patients facing this diagnosis each year in the Netherlands alone. It is also one of the most devastating malignancies and due to relatively young age at presentation (median 59 years), GBMs are responsible for up to 7% of total life years lost from cancer before the age of 70. Despite many efforts, patients with glioblastoma face a poor prognosis, with 2-year survival less than 20%. Current standard of care includes maximal safe surgical resection followed by adjuvant chemoradiation therapy (CRT). Subtotal and gross total resection have been associated with significantly longer survival (median OS: 14.5-18.5 months; RR: 0.71-0.84) 6,7, but in 30% of patients surgery is not feasible. These patients miss the benefit of surgical resection and with CRT alone have a profoundly worse survival (median 5.1 months). Laser interstitial thermal therapy (LITT) is recently growing as a minimally invasive alternative to treat brain tumors. Multiple studies have shown the application of LITT in newly diagnosed and recurrent glioblastoma, in radiotherapy and chemotherapy resistant metastases or in tumors in difficult accessible locations, with promising initial results. A recent systematic review of current phase I/II studies in patients with newly diagnosed irresectable glioblastoma who received LITT yields a mean survival of 10.2 months, i.e. twice as long as with CRT alone (5.1 months). However, there is currently no high-quality prospective evidence directly comparing LITT with standard of care, precluding any conclusions on (cost-)effectiveness. After conducting a pilot study at Radboud University Medical Center to locally confirm safety and feasibility of LITT in patients with irresectable glioblastoma, we propose a prospective multicenter randomized controlled study to evaluate (cost-)effectiveness of this technique.\n\nOBJECTIVE: The primary objective is to prove an improvement in survival without substantially compromising quality-of-life (QoL) in patients with primary irresectable glioblastoma (GBM) treated with LITT plus chemoradiation therapy (CRT) vs. CRT alone.\n\nSTUDY DESIGN: Prospective multicenter randomized controlled trial. Study population: Adult (\\>18 years old) patients with a radiologically suspected diagnosis of primary glioblastoma not amenable for surgical resection.\n\nINTERVENTION: Patients will be randomized to receive either (i) biopsy and LITT, followed by standard CRT or (ii) biopsy alone, followed by standard CRT.\n\nMAIN STUDY PARAMETERS/ENDPOINTS: The primary endpoints are overall survival (OS) and quality-of-life (QoL) using QLQ-C30+BN20 questionnaire 5 months after randomization.\n\nSecondary endpoints are disease-specific and progression-free survival (PFS), generic QoL using EQ5D-5L and QLQ-C30+BN20, complication rates, tumor volume response, effects on adjuvant treatment and costs.\n\nNATURE AND EXTENT OF THE BURDER AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS: We hypothesize that the addition of LITT provides patients with an irresectable glioblastoma a relevant survival benefit without compromising their quality of life as compared to current standard treatment. LITT has been shown to carry limited risk of post-operative complications, mostly reversible, and has been associated with fast recovery post-treatment. The main risks associated to the procedure are bleeding, brain edema, neurological deterioration, operation site infection, epilepsy. The results of our near-finished pilot study are showing that the procedure seems to be safe and feasible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent, age \\>18 years\n* Suspected glioblastoma\n* Supratentorial localization\n* Patient is not amendable for surgical resection as decided by the tumor board\n* Safe trajectory/trajectories possible for ablation of at least 70% of the tumor, avoiding eloquent structures\n* Karnofsky Performance Status (KPS) \\>=70\n\nExclusion Criteria:\n\n* Contra-indication for general anesthesia or MRI\n* Non-glioblastoma diagnosis on pathology analysis\n* No final pathology available\n* Pregnancy\n* Insufficient command of the Dutch language by the patient or a family member, making it impossible to fill in the questionnaires'}, 'identificationModule': {'nctId': 'NCT05318612', 'acronym': 'EMITT', 'briefTitle': 'Effectiveness of MR-guided LITT Therapy in Irresectable Glioblastoma (EMITT)', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': '(Cost)Effectiveness of MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Prospective Multicenter Randomized Controlled Trial (EMITT)', 'orgStudyIdInfo': {'id': 'NL79202.091.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control group (biopsy group)', 'description': 'Standard of care: biopsy + adjuvant treatment', 'interventionNames': ['Procedure: Biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group (LITT group)', 'description': 'Biopsy + LITT + adjuvant treatment', 'interventionNames': ['Procedure: Laser Interstitial Thermal Therapy (LITT)']}], 'interventions': [{'name': 'Laser Interstitial Thermal Therapy (LITT)', 'type': 'PROCEDURE', 'description': 'LITT is a minimally invasive neurosurgical procedure in which a laser catheter is placed into the tumor and warms the tumor to such an extent that tumor tissue is destroyed. LITT is performed under MR-guidance.', 'armGroupLabels': ['Intervention group (LITT group)']}, {'name': 'Biopsy', 'type': 'PROCEDURE', 'description': 'A sample of tissue from the tumor is obtained to confirm the diagnosis.', 'armGroupLabels': ['Control group (biopsy group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Elisabeth Tweesteden Ziekenhuis', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Mark ter Laan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be shared with other researchers. All data will be made findable and shared for reuse and/or verification. Restrictions on data sharing only apply to MRI images due to privacy. Metadata will be published in a data repository (Radboud Data Repository). This way the data is findable. When desired, external researchers can request our data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch National Health Care Institute', 'class': 'OTHER'}, {'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}, {'name': 'UMC Utrecht', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}