[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02840019":3,"trial-entities:NCT02840019":104,"trial-summary:NCT02840019":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":47,"secondary_outcomes":52,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":80,"locations":82,"central_contacts":97,"overall_officials":99,"references":102,"see_also_links":103},"NCT02840019","R01EB017337","Advanced Fetal Imaging - Phase II","RECRUITING","2028-06","2025-11","2025-12-08","2016-07","Boston Children's Hospital","OTHER",false,"The goal of Advanced Fetal Imaging - Phase II is to advance fetal MRI imaging by designing MRI coils specifically for pregnant women and testing recently developed MRI image acquisition techniques. The investigators aim to more reliably obtain higher quality fetal MRI images when compared to current clinical fetal MRI.","The main aim of this project is to evaluate and optimize the existing clinical magnetic resonance (MR) techniques for fetal imaging, and to also implement and test new MR technologies that would improve fetal imaging in general. This involves the development of new pulse sequences and image acquisition schemes that \"freeze\" fetal motion and hence provide improved image quality and robustness for both structural (T1- and T2- weighted, susceptibility and FLAIR imaging) and physiological imaging (diffusion, perfusion, spectroscopy, resting-state functional MRI, etc). The scope of this project also includes testing of newly developed radio frequency (RF) receive-only coil arrays that would inherently provide the means for faster imaging of the fetus, and thus complement the software developments.",[18],"Pregnancy",[20,18,21,22,23,24,25,26],"Fetal MRI","Pregnant Women","MRI Coil","MRI Sequence Development\u002FTesting","Abnormal Fetuses","Typically Developing Fetuses","Fetal MRI Technology Development","INTERVENTIONAL","DIAGNOSTIC",[30],"NA",{"count":32,"type":33},300,"ESTIMATED",[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DEVICE","Investigational MRI coil designed for pregnant women","The investigational MRI receiver coil designed specifically for pregnant women will be used during the 60 minute full research MRI scan. An MRI receiver coil is part of the MRI machine that is placed over the body part being imaged during every MRI scan. A coil is required to obtain MR images, yet there isn't one designed for pregnant women. This investigational MRI receiver coil for pregnant women will be tested to see if it helps improve image quality and take images faster.",[40],"60 minute research full MRI scan",{"type":42,"name":43,"description":44,"armGroupLabels":45},"PROCEDURE","MRI Scan","All participants will participate in an MRI scan. The add-on MRI scan will be 15 minutes. The full MRI scan will be 60 minutes.",[46,40],"15 minute research add-on MRI scan",[48],{"measure":49,"description":50,"timeFrame":51},"Research fetal MRI image quality compared to standard clinical fetal MRI image quality","Research fetal MRI image quality will be compared to the standard clinical fetal MRI image quality.","July 2016-December 2019, up to 41 months",[53,56],{"measure":54,"description":55,"timeFrame":51},"Research fetal MRI image quality compared to standard obstetric ultrasound image quality","Research fetal MRI image quality will be compared against standard obstetric ultrasound image quality.",{"measure":57,"description":58,"timeFrame":51},"Research MRI physiological data compared against standard obstetric physiological data obtained from ultrasound","Research fetal MRI physiology data (flow, perfusion, oxygen consumption) will be compared against standard obstetric physiological data obtained from ultrasound (e.g. Doppler measures).","FEMALE","18 Years","45 Years",true,{"inclusion":64,"exclusion":75,"raw_text":79},[65,66,67,68,69,70,69,71,72,66,67,73,67,74],"60 Minute Full Research MRI Scan:","Gestational age between 18 and 40 weeks","AND","Pregnant women with a healthy pregnancy","OR","Pregnant women with a concern for fetal\u002Fplacental abnormalities referred for a clinical fetal MRI by their obstetrician","Pregnant women with a concern for fetal\u002Fplacental abnormalities NOT referred for a clinical fetal MRI by their obstetrician","15 Minute Add-On Research Scan:","Pregnant women with a concern for fetal abnormalities referred for a clinical fetal MRI by their obstetrician","The clinical fetal MRI will occur at Boston Children's Hospital",[76,77,78],"Pregnant women with a contraindication to MRI (implanted metal, non-removable piercings, pacemaker, etc)","Pregnant women who are claustrophobic","Pregnant women who are medically unstable for an MRI","Inclusion Criteria:\n\n* 60 Minute Full Research MRI Scan:\n\n  * Gestational age between 18 and 40 weeks\n\n    * AND\n  * Pregnant women with a healthy pregnancy\n\n    * OR\n  * Pregnant women with a concern for fetal\u002Fplacental abnormalities referred for a clinical fetal MRI by their obstetrician\n\n    * OR\n  * Pregnant women with a concern for fetal\u002Fplacental abnormalities NOT referred for a clinical fetal MRI by their obstetrician\n* 15 Minute Add-On Research Scan:\n\n  * Gestational age between 18 and 40 weeks\n\n    * AND\n  * Pregnant women with a concern for fetal abnormalities referred for a clinical fetal MRI by their obstetrician\n\n    * AND\n  * The clinical fetal MRI will occur at Boston Children's Hospital\n\nExclusion Criteria:\n\n* Pregnant women with a contraindication to MRI (implanted metal, non-removable piercings, pacemaker, etc)\n* Pregnant women who are claustrophobic\n* Pregnant women who are medically unstable for an MRI",[81],"ADULT",[83],{"facility":12,"status":7,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":94},"Boston","Massachusetts","02115","United States",[89],{"name":90,"role":91,"phone":92,"email":93},"P. Ellen Grant, MD","CONTACT","857-218-5111","ellen.grant@childrens.harvard.edu",{"lat":95,"lon":96},42.35843,-71.05977,[98],{"name":90,"role":91,"phone":92,"email":93},[100],{"name":90,"affiliation":12,"role":101},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":105,"biomarkers":107},[106,18],"Dental abnormalities",[],{"nct_id":4,"found":62,"summary":109,"prompt_version":118},{"design":110,"status":111,"heading":6,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This interventional study plans to enroll 300 pregnant women to evaluate a new investigational MRI coil.","completed","This study, called Advanced Fetal Imaging - Phase II, is testing a new investigational MRI coil designed specifically for pregnant women. This special coil is part of the MRI machine and is placed over the body part being imaged. The goal is to see if this new coil, along with new MRI techniques, can create clearer and more reliable fetal MRI images compared to the standard MRI images currently used. You could join if you are a pregnant woman between 18 and 45 years old, with a healthy pregnancy or if there's a concern about your baby or placenta that would typically lead to a fetal MRI. The study aims to enroll 300 participants, but its current recruitment status is unclear.","The quality of the research fetal MRI images will be compared to standard images for up to 41 months (July 2016-December 2019).",121,"You would participate in an MRI scan, which includes a 60-minute full research MRI scan and potentially an additional 15-minute MRI scan.","Not stated in the trial record.",[],"v2"]