Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-30 @ 7:42 PM
Study NCT ID:
NCT04455932
Status:
RECRUITING
Last Update Posted:
2021-09-08
First Post:
2020-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 476}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-06', 'studyFirstSubmitDate': '2020-06-27', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HCC detection with US surveillance versus aNC-MRI surveillance', 'timeFrame': '3 or 5 years', 'description': 'The detection of hepatic malignancy on the two modalities will be compared\n\n* Sensitivity, specificity, PPV and NPV of HCC detection with US surveillance vs aNC-MRI surveillance\n* Correlation with diagnostic imaging (multiphase CT or MRI) and/or histopathology as a reference standard\n\nFor the diagnosis of HCC we will accept\n\n* Imaging diagnosis based on the Liver Imaging Reporting and Data System (LI-RADS)\n* Any pathological proof on biopsy or excision The HCC will then be staged based on the Barcelona clinic liver cancer (BCLC) staging system\n\nFor the diagnosis of non-HCC hepatic malignancy we will accept\n\n* Imaging diagnosis based on the Liver Imaging Reporting and Data System (LI-RADS)\n* Any pathological proof on biopsy or excision'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound', 'MRI', 'HCC', 'Hepatocellular carcinoma', 'aMRI', 'NC-aMRI', 'Screening', 'Surveillance'], 'conditions': ['Hepatocellular Carcinoma', 'HCC']}, 'referencesModule': {'references': [{'pmid': '31210614', 'type': 'RESULT', 'citation': 'Son JH, Choi SH, Kim SY, Jang HY, Byun JH, Won HJ, Lee SJ, Lim YS. Validation of US Liver Imaging Reporting and Data System Version 2017 in Patients at High Risk for Hepatocellular Carcinoma. Radiology. 2019 Aug;292(2):390-397. doi: 10.1148/radiol.2019190035. Epub 2019 Jun 18.'}, {'pmid': '24691105', 'type': 'RESULT', 'citation': 'Singal AG, Pillai A, Tiro J. Early detection, curative treatment, and survival rates for hepatocellular carcinoma surveillance in patients with cirrhosis: a meta-analysis. PLoS Med. 2014 Apr 1;11(4):e1001624. doi: 10.1371/journal.pmed.1001624. eCollection 2014 Apr.'}, {'pmid': '29425931', 'type': 'RESULT', 'citation': 'Tzartzeva K, Obi J, Rich NE, Parikh ND, Marrero JA, Yopp A, Waljee AK, Singal AG. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018 May;154(6):1706-1718.e1. doi: 10.1053/j.gastro.2018.01.064. Epub 2018 Feb 6.'}, {'pmid': '26830614', 'type': 'RESULT', 'citation': 'Hanna RF, Miloushev VZ, Tang A, Finklestone LA, Brejt SZ, Sandhu RS, Santillan CS, Wolfson T, Gamst A, Sirlin CB. Comparative 13-year meta-analysis of the sensitivity and positive predictive value of ultrasound, CT, and MRI for detecting hepatocellular carcinoma. Abdom Radiol (NY). 2016 Jan;41(1):71-90. doi: 10.1007/s00261-015-0592-8.'}, {'pmid': '16542288', 'type': 'RESULT', 'citation': 'Colli A, Fraquelli M, Casazza G, Massironi S, Colucci A, Conte D, Duca P. Accuracy of ultrasonography, spiral CT, magnetic resonance, and alpha-fetoprotein in diagnosing hepatocellular carcinoma: a systematic review. Am J Gastroenterol. 2006 Mar;101(3):513-23. doi: 10.1111/j.1572-0241.2006.00467.x.'}, {'pmid': '30251931', 'type': 'RESULT', 'citation': 'Chernyak V, Fowler KJ, Kamaya A, Kielar AZ, Elsayes KM, Bashir MR, Kono Y, Do RK, Mitchell DG, Singal AG, Tang A, Sirlin CB. Liver Imaging Reporting and Data System (LI-RADS) Version 2018: Imaging of Hepatocellular Carcinoma in At-Risk Patients. Radiology. 2018 Dec;289(3):816-830. doi: 10.1148/radiol.2018181494. Epub 2018 Sep 25.'}, {'pmid': '29628281', 'type': 'RESULT', 'citation': 'European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.'}, {'pmid': '31041073', 'type': 'RESULT', 'citation': "D'Avola D, Labgaa I, Villanueva A. Natural history of nonalcoholic steatohepatitis/nonalcoholic fatty liver disease-hepatocellular carcinoma: Magnitude of the problem from a hepatology clinic perspective. Clin Liver Dis (Hoboken). 2016 Oct 27;8(4):100-104. doi: 10.1002/cld.579. eCollection 2016 Oct. No abstract available."}, {'pmid': '20175765', 'type': 'RESULT', 'citation': 'Saunders D, Seidel D, Allison M, Lyratzopoulos G. Systematic review: the association between obesity and hepatocellular carcinoma - epidemiological evidence. Aliment Pharmacol Ther. 2010 May;31(10):1051-63. doi: 10.1111/j.1365-2036.2010.04271.x. Epub 2010 Feb 18.'}, {'pmid': '21544812', 'type': 'RESULT', 'citation': 'Wang C, Wang X, Gong G, Ben Q, Qiu W, Chen Y, Li G, Wang L. Increased risk of hepatocellular carcinoma in patients with diabetes mellitus: a systematic review and meta-analysis of cohort studies. Int J Cancer. 2012 Apr 1;130(7):1639-48. doi: 10.1002/ijc.26165. Epub 2011 Jul 28.'}, {'pmid': '26707365', 'type': 'RESULT', 'citation': 'Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.'}, {'pmid': '28692197', 'type': 'RESULT', 'citation': 'Chitturi S, Wong VW, Chan WK, Wong GL, Wong SK, Sollano J, Ni YH, Liu CJ, Lin YC, Lesmana LA, Kim SU, Hashimoto E, Hamaguchi M, Goh KL, Fan J, Duseja A, Dan YY, Chawla Y, Farrell G, Chan HL. The Asia-Pacific Working Party on Non-alcoholic Fatty Liver Disease guidelines 2017-Part 2: Management and special groups. J Gastroenterol Hepatol. 2018 Jan;33(1):86-98. doi: 10.1111/jgh.13856. No abstract available.'}, {'pmid': '28476736', 'type': 'RESULT', 'citation': "Benson AB 3rd, D'Angelica MI, Abbott DE, Abrams TA, Alberts SR, Saenz DA, Are C, Brown DB, Chang DT, Covey AM, Hawkins W, Iyer R, Jacob R, Karachristos A, Kelley RK, Kim R, Palta M, Park JO, Sahai V, Schefter T, Schmidt C, Sicklick JK, Singh G, Sohal D, Stein S, Tian GG, Vauthey JN, Venook AP, Zhu AX, Hoffmann KG, Darlow S. NCCN Guidelines Insights: Hepatobiliary Cancers, Version 1.2017. J Natl Compr Canc Netw. 2017 May;15(5):563-573. doi: 10.6004/jnccn.2017.0059."}, {'pmid': '25965437', 'type': 'RESULT', 'citation': 'Burak KW, Sherman M. Hepatocellular carcinoma: Consensus, controversies and future directions. A report from the Canadian Association for the Study of the Liver Hepatocellular Carcinoma Meeting. Can J Gastroenterol Hepatol. 2015 May;29(4):178-84. doi: 10.1155/2015/824263.'}, {'pmid': '28130846', 'type': 'RESULT', 'citation': 'Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.'}, {'pmid': '25625806', 'type': 'RESULT', 'citation': 'Kokudo N, Hasegawa K, Akahane M, Igaki H, Izumi N, Ichida T, Uemoto S, Kaneko S, Kawasaki S, Ku Y, Kudo M, Kubo S, Takayama T, Tateishi R, Fukuda T, Matsui O, Matsuyama Y, Murakami T, Arii S, Okazaki M, Makuuchi M. Evidence-based Clinical Practice Guidelines for Hepatocellular Carcinoma: The Japan Society of Hepatology 2013 update (3rd JSH-HCC Guidelines). Hepatol Res. 2015 Jan;45(2). doi: 10.1111/hepr.12464.'}, {'pmid': '25135008', 'type': 'RESULT', 'citation': 'Marrero JA, Ahn J, Rajender Reddy K; Americal College of Gastroenterology. ACG clinical guideline: the diagnosis and management of focal liver lesions. Am J Gastroenterol. 2014 Sep;109(9):1328-47; quiz 1348. doi: 10.1038/ajg.2014.213. Epub 2014 Aug 19.'}, {'pmid': '25918260', 'type': 'RESULT', 'citation': 'Korean Liver Cancer Study Group (KLCSG); National Cancer Center, Korea (NCC). 2014 KLCSG-NCC Korea Practice Guideline for the Management of Hepatocellular Carcinoma. Gut Liver. 2015 May 23;9(3):267-317. doi: 10.5009/gnl14460.'}, {'pmid': '27448609', 'type': 'RESULT', 'citation': 'Besa C, Lewis S, Pandharipande PV, Chhatwal J, Kamath A, Cooper N, Knight-Greenfield A, Babb JS, Boffetta P, Padron N, Sirlin CB, Taouli B. Hepatocellular carcinoma detection: diagnostic performance of a simulated abbreviated MRI protocol combining diffusion-weighted and T1-weighted imaging at the delayed phase post gadoxetic acid. Abdom Radiol (NY). 2017 Jan;42(1):179-190. doi: 10.1007/s00261-016-0841-5.'}, {'pmid': '29246586', 'type': 'RESULT', 'citation': 'Tillman BG, Gorman JD, Hru JM, Lee MH, King MC, Sirlin CB, Marks RM. Diagnostic per-lesion performance of a simulated gadoxetate disodium-enhanced abbreviated MRI protocol for hepatocellular carcinoma screening. Clin Radiol. 2018 May;73(5):485-493. doi: 10.1016/j.crad.2017.11.013. Epub 2017 Dec 12.'}, {'pmid': '29018942', 'type': 'RESULT', 'citation': 'Lee JY, Huo EJ, Weinstein S, Santos C, Monto A, Corvera CU, Yee J, Hope TA. Evaluation of an abbreviated screening MRI protocol for patients at risk for hepatocellular carcinoma. Abdom Radiol (NY). 2018 Jul;43(7):1627-1633. doi: 10.1007/s00261-017-1339-5.'}, {'pmid': '31853685', 'type': 'RESULT', 'citation': 'Chan MV, McDonald SJ, Ong YY, Mastrocostas K, Ho E, Huo YR, Santhakumar C, Lee AU, Yang J. HCC screening: assessment of an abbreviated non-contrast MRI protocol. Eur Radiol Exp. 2019 Dec 18;3(1):49. doi: 10.1186/s41747-019-0126-1.'}, {'pmid': '31858203', 'type': 'RESULT', 'citation': 'Park SH, Kim B, Kim SY, Shim YS, Kim JH, Huh J, Kim HJ, Kim KW, Lee SS. Abbreviated MRI with optional multiphasic CT as an alternative to full-sequence MRI: LI-RADS validation in a HCC-screening cohort. Eur Radiol. 2020 Apr;30(4):2302-2311. doi: 10.1007/s00330-019-06546-5. Epub 2019 Dec 19.'}, {'pmid': '25539238', 'type': 'RESULT', 'citation': 'Lewis S, Kamath A, Chatterji M, Patel A, Shyknevsky I, Dyvorne HA, Kuehn B, Taouli B. Diffusion-weighted imaging of the liver in patients with chronic liver disease: comparison of monopolar and bipolar diffusion gradients for image quality and lesion detection. AJR Am J Roentgenol. 2015 Jan;204(1):59-68. doi: 10.2214/AJR.13.11695.'}, {'pmid': '32166493', 'type': 'RESULT', 'citation': 'Whang S, Choi MH, Choi JI, Youn SY, Kim DH, Rha SE. Comparison of diagnostic performance of non-contrast MRI and abbreviated MRI using gadoxetic acid in initially diagnosed hepatocellular carcinoma patients: a simulation study of surveillance for hepatocellular carcinomas. Eur Radiol. 2020 Aug;30(8):4150-4163. doi: 10.1007/s00330-020-06754-4. Epub 2020 Mar 12.'}, {'pmid': '29624699', 'type': 'RESULT', 'citation': 'Marrero JA, Kulik LM, Sirlin CB, Zhu AX, Finn RS, Abecassis MM, Roberts LR, Heimbach JK. Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2018 Aug;68(2):723-750. doi: 10.1002/hep.29913. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.acr.org/-/media/ACR/Files/RADS/LI-RADS/CEUS-LI-RADS-2017-Core.pdf?la=en%20n.d', 'label': 'US LIRADS CORE 2017'}]}, 'descriptionModule': {'briefSummary': 'All international guidelines recommend 6-monthly ultrasound surveillance for patients at risk for liver cancer (hepatocellular carcinoma or HCC), such as patients with cirrhosis. The aim of surveillance is to detect HCC at an early stage when it is still potentially curable. Currently only 4 out of 10 HCCs are detected at the early stage.\n\nUltrasound surveillance for HCC has a wide ranging sensitivity, dependent on many factors such as operator experience, patient body habitus and liver parenchymal heterogeneity due to chronic liver disease and cirrhosis. In a select group of patients, surveillance ultrasound can be suboptimal or near non-diagnostic.\n\nCurrently no guideline offers an alternative surveillance tool for patients who have suboptimal surveillance ultrasounds.', 'detailedDescription': 'The investigators plan to conduct a prospective study to examine the diagnostic performance of abbreviated non-contrast MRI (aNC-MRI) versus ultrasound, in a select group of cirrhotic patients with poor ultrasound visualisation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Patients with cirrhosis (all causes of cirrhosis, except obscure causes such as vascular or congenital fibrosis) AND reduced visualisation of their liver on ultrasound (vB and vC).\n* The criteria of cirrhosis can be obtained with any of the following methods:\n\n 1. Histologically by liver biopsy\n 2. Past signs of decompensated liver disease such as ascites, encephalopathy, varices or bacterial peritonitis\n 3. Clinically suspicion of cirrhosis PLUS one of the following:\n\n 1. Radiological evidence of morphologic changes of the liver and evidence of portal hypertension on US, CT or MRI examinations, including the identification of hepatic surface nodularity, splenomegaly, portal collaterals, varices and ascites\n 2. Fibroscan (transient elastography) median liver stiffness \\>12.5 kPa, the Fibroscan must be performed by an experienced technician and interpreted by the hepatologist\n 3. Platelet count \\<100 (x10\\^9/L) with no alternative cause\n* Absence of previous history or current suspicion of HCC - Absence of HCC is defined by liver US, multiphase CT or contrast-enhanced MRI within 6 months prior to surveillance\n* Patient is able to comply with scheduled visits, evaluation plans and other study procedures in the opinion of the investigator\n* Patient is willing to provide written informed consent\n\nExclusion criteria\n\n* Contraindications to MRI scan (defibrillator, pacemaker, metallic foreign body, severe claustrophobia etc.)\n* Contraindications to gadolinium\n* Age above 85 years old or younger than 20 years old\n* Pregnancy or breast feeding\n* Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrolment for the trial or could interfere with the completion of the study'}, 'identificationModule': {'nctId': 'NCT04455932', 'briefTitle': 'HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation', 'organization': {'class': 'OTHER', 'fullName': 'Concord Repatriation General Hospital'}, 'officialTitle': 'HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation', 'orgStudyIdInfo': {'id': '2019/PID15472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HCC surveillance with US and aNC-MRI', 'interventionNames': ['Diagnostic Test: Abbreviated non-contrast MRI of the liver', 'Diagnostic Test: Ultrasound surveillance', 'Diagnostic Test: Multiphase contrast-enhanced liver MRI']}], 'interventions': [{'name': 'Abbreviated non-contrast MRI of the liver', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['aNC-MRI'], 'description': 'every 6 months', 'armGroupLabels': ['HCC surveillance with US and aNC-MRI']}, {'name': 'Ultrasound surveillance', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['US surveillance'], 'description': 'every 6 months', 'armGroupLabels': ['HCC surveillance with US and aNC-MRI']}, {'name': 'Multiphase contrast-enhanced liver MRI', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Multiphase liver MRI'], 'description': 'screening', 'armGroupLabels': ['HCC surveillance with US and aNC-MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Yu Xuan Kitzing', 'role': 'CONTACT'}, {'name': 'Yu Xuan Kitzing', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Simone Strasser', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2139', 'city': 'Concord', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Jessica Yang', 'role': 'CONTACT'}, {'name': 'Alice Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emily He', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeff Chang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jessica Yang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Concord Repatriation General Hospital', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'city': 'Gosford', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Jonathan Ho', 'role': 'CONTACT'}, {'name': 'Susanna Won', 'role': 'CONTACT'}, {'name': 'Jonathan Ho', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Susanna Won', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Satbir Singh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gosford Hospital', 'geoPoint': {'lat': -33.4244, 'lon': 151.34399}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Dean Rabinowitz', 'role': 'CONTACT'}, {'name': 'Dean Rabinowitz', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stephen Riordan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Jacob George', 'role': 'CONTACT'}, {'name': 'Anthony Peduto', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jacob George', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Brisbane', 'state': 'Queensland', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Kate McLean', 'role': 'CONTACT'}, {'name': 'Kate McLean', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Katherine Stuart', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Caroline Tallis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Tom Sutherland', 'role': 'CONTACT'}, {'name': 'Tom Sutherland', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St Vincent's Hospital Melbourne", 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Numan Kutaiba', 'role': 'CONTACT'}, {'name': 'Numan Kutaiba', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Austin Hospital', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'city': 'Perth', 'state': 'Western Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'James Seow', 'role': 'CONTACT'}, {'name': 'James Seow', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wendy Cheng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '0620', 'city': 'Takapuna', 'state': 'Auckland', 'status': 'NOT_YET_RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'Chris McKee', 'role': 'CONTACT'}, {'name': 'Chris McKee', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jash Agraval', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'John Perry', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Shore Hospital', 'geoPoint': {'lat': -36.79167, 'lon': 174.77583}}], 'centralContacts': [{'name': 'Jessica Yang, MBBS', 'role': 'CONTACT', 'email': 'jessica.yang1@health.nsw.gov.au', 'phone': '+61297676495'}, {'name': 'Isaac Lui, MD', 'role': 'CONTACT', 'email': 'dr.isaac.lui@gmail.com'}], 'overallOfficials': [{'name': 'Jessica Yang, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Concord Repatriation General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Concord Repatriation General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Jessica Yang', 'investigatorAffiliation': 'Concord Repatriation General Hospital'}}}}