[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05697406":3,"trial-entities:NCT05697406":92,"trial-summary:NCT05697406":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":59,"locations":62,"central_contacts":78,"overall_officials":79,"references":80,"see_also_links":91},"NCT05697406","HP-00101177","HP Pyruvate MRI in Cancers","Hyperpolarized 13-C Pyruvate MRI Surveillance of Multiple Cancers","RECRUITING","2028-12-01","2025-09","2025-09-22","2024-06-24","University of Maryland, Baltimore","OTHER",true,"Many human diseases are characterized by their ability to alter existing metabolic pathways and interrupt cellular processes. Cancer exploits the Warburg effect and utilizes greater glucose than normal cells and within this process uses anaerobic respiration, leading to increased conversion of pyruvate to lactate. This can be exploited by hyperpolarized imaging. Hyperpolarized 13C MRI imaging is an approach that utilizes a stable isotope of Carbon (13C) linked to pyruvate. MRI spectroscopy is used in conjunction with hyperpolarized 13C pyruvate in order to temporally detect pyruvate and its conversion to lactate in-vivo, in order to visualize downstream metabolic (glycolytic) activity secondary to the Warburg effect, which should be useful in detecting and characterizing tumors of various types. Hyperpolarized 13C pyruvate MR imaging has not been tested in most cancers. In this preliminary survey, we will test the hypothesis that hyperpolarized 13C pyruvate MR imaging can be used to image various cancers.","Most cancers exhibit the Warburg effect, which involves synthesis of lactate via glycolytic pathways. The present method of using 18F-FDG to image metabolic events only evaluates early glycolysis and does not investigate late glycolytic effects which can be examined by 13C pyruvate. The ability to detect cancer using 13C pyruvate has been shown using ovarian cancer models and in the prostate in humans, however its utility in other tumors needs clarification. Because cancers of various types affect metabolic pathways, it is necessary to improve imaging techniques to better investigate downstream metabolism. Many studies have shown that there are higher lactate levels in cancer tissue and higher levels of glycolysis. 13C pyruvate imaging takes advantage of these pathways by imaging the tumors while undergoing pyruvate to lactate conversion . From this modality, a three dimensional visualization of the tumor and metabolic products created by the pyruvate can be investigated.",[19,20,21],"Image","Warburg Effect","Tumors",[],"INTERVENTIONAL","DIAGNOSTIC",[26,27],"PHASE1","PHASE2",{"count":29,"type":30},25,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Hyperpolarized 13C-Pyruvate","Imaging tumors pre and post administration of hyperpolarized 13-C pyruvate injection.",[37],"Experimental",[39],{"measure":40,"description":41,"timeFrame":42},"Pyruvate to Lactate Conversion","Imaging Quality, KpL","18-36 months",[44,48],{"measure":45,"description":46,"timeFrame":47},"SNR","Signal to Noise Ratio, dB","12-42 months",{"measure":49,"description":50,"timeFrame":47},"CNR","Contrast to Noise","ALL","18 Years","88 Years",false,{"inclusion":56,"exclusion":57,"raw_text":58},[],[],"Inclusion Criteria:\n\nClinical tumor diagnosis\n\nPatients with pre-existing MR imaging appointments\n\nMust be able to undergo MR\n\nExclusion Criteria:\n\nNo tumor diagnosis",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":64,"status":8,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":75},"University of Maryland Medical Center","Baltimore","Maryland","21201","United States",[70],{"name":71,"role":72,"phone":73,"email":74},"Rosy Njonkou, MA","CONTACT","410-706-0943","rnjonkou@som.umaryland.edu",{"lat":76,"lon":77},39.29038,-76.61219,[],[],[81,85,88],{"pmid":82,"type":83,"citation":84},"18922937","BACKGROUND","Albers MJ, Bok R, Chen AP, Cunningham CH, Zierhut ML, Zhang VY, Kohler SJ, Tropp J, Hurd RE, Yen YF, Nelson SJ, Vigneron DB, Kurhanewicz J. Hyperpolarized 13C lactate, pyruvate, and alanine: noninvasive biomarkers for prostate cancer detection and grading. Cancer Res. 2008 Oct 15;68(20):8607-15. doi: 10.1158\u002F0008-5472.CAN-08-0749.",{"pmid":86,"type":83,"citation":87},"28707963","Ravoori MK, Singh SP, Lee J, Bankson JA, Kundra V. In Vivo Assessment of Ovarian Tumor Response to Tyrosine Kinase Inhibitor Pazopanib by Using Hyperpolarized 13C-Pyruvate MR Spectroscopy and 18F-FDG PET\u002FCT Imaging in a Mouse Model. Radiology. 2017 Dec;285(3):830-838. doi: 10.1148\u002Fradiol.2017161772. Epub 2017 Jul 13.",{"pmid":89,"type":83,"citation":90},"30835184","Wang ZJ, Ohliger MA, Larson PEZ, Gordon JW, Bok RA, Slater J, Villanueva-Meyer JE, Hess CP, Kurhanewicz J, Vigneron DB. Hyperpolarized 13C MRI: State of the Art and Future Directions. Radiology. 2019 May;291(2):273-284. doi: 10.1148\u002Fradiol.2019182391. Epub 2019 Mar 5.",[],{"nct_id":4,"conditions":93,"biomarkers":95},[94],"Solid Neoplasm",[],{"nct_id":4,"found":15,"summary":97,"prompt_version":106},{"design":98,"status":99,"heading":6,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an interventional study planning to enroll 25 participants. The phase of the study is not specified.","completed","This study is looking at a special type of MRI imaging called Hyperpolarized 13C-Pyruvate MRI to better see and understand tumors. Many cancers use sugar differently than healthy cells, a process called the Warburg effect, which leads to more pyruvate being turned into lactate. This study uses a special form of carbon (13C) attached to pyruvate, which is then injected into your body. The MRI can then track how this pyruvate changes into lactate in your tumors, helping doctors visualize this metabolic activity. You may be able to join if you have a cancer diagnosis, are between 18 and 88 years old, and already have an MRI appointment. The main goal is to measure how much pyruvate converts to lactate in tumors over 18 to 36 months. The current status of this study is unclear.","The primary endpoint, pyruvate to lactate conversion, will be measured at 18-36 months.",135,"You would undergo MRI imaging before and after receiving an injection of Hyperpolarized 13C-Pyruvate.","Not stated in the trial record.",[34],"v2"]