[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04368702":3,"trial-entities:NCT04368702":142,"trial-summary:NCT04368702":149},{"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":25,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":47,"secondary_outcomes":65,"sex":92,"minimum_age":93,"maximum_age":94,"healthy_volunteers":95,"eligibility_criteria":96,"std_ages":108,"locations":111,"central_contacts":133,"overall_officials":137,"references":140,"see_also_links":141},"NCT04368702","19-665","CONFIRM: Magnetic Resonance Guided Radiation Therapy","Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol","RECRUITING","2029-06-18","2026-01","2026-02-09","2021-05-01","Brigham and Women's Hospital","OTHER",true,"This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.","This is a master clinical protocol evaluating magnetic resonance (MR) image guided radiation in patients with gastric and breast cancer.\n\nIn this research study, the investigators are researching if getting an MRI during radiation is a feasible way to delivery radiation. In this research study, a MRI done during treatment will help doctors adapt the radiation to target the most precise spot where the cancer is located.\n\nThe research study procedures include:\n\n* Screening for eligibility\n* Study treatment including evaluations\n* Follow up visits\n* Questionnaires\n\nThis is a Phase I\u002FII clinical trial. A Phase I clinical trial tests the safety of investigational radiation treatment and also tries to define the appropriate dose of the investigational radiation treatment to use for further studies. \"Investigational\" means that the way the radiation treatment is delivered is being studied.\n\nThis research study is a Feasibility Study, which means it is the first-time investigators at this institution are examining this type of MR-guided radiation. Investigators at other hospitals and academic centers are already using this type of radiation.\n\nThe U.S. Food and Drug Administration (FDA) has approved this radiation machine and these drugs as treatment options for gastric and breast cancer.",[19,20,21,22,23,24],"Gastric Cancer","Invasive Breast Cancer","in Situ Breast Cancer","Mantle Cell Lymphoma","Larynx Cancer","Bladder Cancer",[19,20,21,26,27,28],"Lymphoma","Larynx","Bladder","INTERVENTIONAL","TREATMENT",[32],"NA",{"count":34,"type":35},70,"ESTIMATED",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41},"RADIATION","Viewray MRIdian® Linac","MR-image guided radiation will be administered per disease site standards.",[42,43,44,45,46],"Phase I - Bladder","Phase I - Breast Cancer","Phase I - Gastric Cancer","Phase I - Larynx","Phase I - Mantle Cell Lymphoma",[48,52,55,59,62],{"measure":49,"description":50,"timeFrame":51},"Number of Patients and delivering MR-image guided radiation-Phase I","Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as Enrolling patients and delivering MR-image guided radiation on the MR Linac","5 weeks",{"measure":53,"description":54,"timeFrame":51},"Tumor Assessment with MR Guidance-Phase I","Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as assessing tumor using MR guidance before, during and after MR-guided treatment patient.",{"measure":56,"description":57,"timeFrame":58},"Patient reported outcomes (PROMs) -Phase II","PROMs are collected at patient visits. PROMs will be evaluated using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS Global-10 metric collects information on symptoms and quality of life.","1 year",{"measure":60,"description":61,"timeFrame":58},"1-year tumor control-Phase II","Tumor response 1 year after radiation treatment",{"measure":63,"description":64,"timeFrame":58},"Rate of Pathologic complete response-Gastric","full pathological review of surgical specimen according to the AJCC Staging Classification, 8th edition. pCR will be defined as the absence of any viable tumor cells within the pathologic specimen.",[66,70,72,76,80,84,88],{"measure":67,"description":68,"timeFrame":69},"Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.","Toxicity of MRgRT with concurrent chemotherapy will be summarized by category and grade according to CTCAE version 5.0.","90 Days",{"measure":67,"description":71,"timeFrame":58},"CTCAE version 5.0.",{"measure":73,"description":74,"timeFrame":75},"Duration of treatment with goal of >80% of cases treated within 90 minutes","Total time of treatment for each fraction","7 weeks",{"measure":77,"description":78,"timeFrame":79},"Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without MR-image guided radiation.","Importance of MR-guidance","5 Weeks",{"measure":81,"description":82,"timeFrame":83},"Progression Free Survival","Estimated using the Kaplan Meier method with 95% confidence intervals based on the complementary log-log transformation.","irst date of protocol therapy to the earliest date of disease progression per RECIST criteria or death due to any cause up to 12 Months",{"measure":85,"description":86,"timeFrame":87},"Overall Survival","The OS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.","irst date of protocol therapy to the date of death due to any cause. OS time will be censored at the date of last follow-up for patients still alive up to 1 year",{"measure":89,"description":90,"timeFrame":91},"Characterizing MRI-based tumor alterations\u002Fchanges following MR-image guided radiation","Evaluation of tumor response following treatment","1 Year","ALL","18 Years",null,false,{"inclusion":97,"exclusion":103,"raw_text":107},[98,99,100,101,102],"Participants must have histologically or cytologically confirmed malignancy requiring radiation","Age 18 years of older","ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)","Ability to understand and the willingness to sign a written informed consent document.","Any further criteria listed in the specific disease site cohort",[104,105,106],"History of allergic reactions attributed to gadolinium-based IV contrast","Severe claustrophobia or anxiety","Participants who cannot undergo an MRI","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed malignancy requiring radiation\n* Age 18 years of older\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)\n* Ability to understand and the willingness to sign a written informed consent document.\n* Any further criteria listed in the specific disease site cohort\n\nExclusion Criteria\n\n* History of allergic reactions attributed to gadolinium-based IV contrast\n\n  \\-- Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility\n* Severe claustrophobia or anxiety\n* Participants who cannot undergo an MRI\n* Any other exclusion criteria listed in the specific disease site cohort",[109,110],"ADULT","OLDER_ADULT",[112,127],{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":117,"contacts":118,"geoPoint":124},"Brigham & Women's Hospital","Boston","Massachusetts","02115","United States",[119,122],{"name":120,"role":121},"Raymond Mak, MD","CONTACT",{"name":120,"role":123},"PRINCIPAL_INVESTIGATOR",{"lat":125,"lon":126},42.35843,-71.05977,{"facility":128,"status":8,"city":114,"state":115,"zip":116,"country":117,"contacts":129,"geoPoint":132},"Dana Farber Cancer Institute",[130,131],{"name":120,"role":121},{"name":120,"role":123},{"lat":125,"lon":126},[134],{"name":120,"role":121,"phone":135,"email":136},"6177328651","rmak@partners.org",[138],{"name":120,"affiliation":139,"role":123},"Dana-Farber Cancer Institute",[],[],{"nct_id":4,"conditions":143,"biomarkers":148},[144,145,146,147,22],"Bladder Carcinoma","Breast Carcinoma","Gastric Carcinoma","Malignant Laryngeal Neoplasm",[],{"nct_id":4,"found":15,"summary":150,"prompt_version":160},{"design":151,"status":152,"heading":153,"summary":154,"follow_up":155,"word_count":156,"commitments":157,"compensation":158,"drugs_mentioned":159},"This is a Phase I\u002FII interventional study, meaning it tests a new treatment approach. It plans to include 70 participants.","completed","CONFIRM: MR-Guided Radiation Therapy for Gastric and Breast Cancer","This study, called CONFIRM, is looking at how safe and practical it is to use a special type of radiation therapy guided by magnetic resonance imaging (MRI) for people with gastric (stomach) cancer or breast cancer. The treatment uses a machine called the Viewray MRIdian® Linac. Doctors hope that using MRI during radiation will help them target the cancer more precisely. The study will measure how many patients can receive this treatment and how well it works on tumors. We will also ask about your experiences and well-being for up to one year. This is a Phase I\u002FII study, meaning it's testing the safety of this new way of delivering radiation and finding the right dose. The study aims to enroll 70 participants aged 18 or older who have cancer requiring radiation.","Your well-being will be assessed for up to one year after treatment.",132,"You would go through screening, receive study treatment with evaluations, attend follow-up visits, and complete questionnaires.","Not stated in the trial record.",[39],"v2"]