[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06548776":3,"trial-entities:NCT06548776":97,"trial-summary:NCT06548776":102},{"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":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":67,"locations":70,"central_contacts":86,"overall_officials":89,"references":92,"see_also_links":93},"NCT06548776","2024-0249","Establishing Daily Applicable Parameters for Using Magnetic Resonance Spectroscopy of Spinal Cord","RECRUITING","2028-07-31","2026-08","2026-08-06","2024-09-04","M.D. Anderson Cancer Center","OTHER",false,"To learn if MRS can effectively assess spinal cord lesions.","Primary Objective:\n\nEstablish the feasibility and spectrum of MRS for adult patients while mapping the total spine spectrum at short TEs to allow for future comparison with patients to assess spinal cord lesions malignant potential and grade.\n\nSecondary Objective:\n\nTest success of the spectrum by implementing the protocol on 3 low volume LMD receiving LMD receiving CSI. This will allow us to test reproducibility of the protocol and test effect of radiation on spinal cord at different time frames. This will serve as secondary data for subsequent trials targeting functional statues after radiation and tumor grading predictability of MRS.",[18],"Spinal Cord",[],"INTERVENTIONAL","DIAGNOSTIC",[23],"NA",{"count":25,"type":26},13,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DIAGNOSTIC_TEST","Magnetic Resonance Spectroscopy (MRS) Scan","Participants will receive MRS Scan",[33,34],"Healthy Volunteers","Patients",[36],{"measure":37,"description":38,"timeFrame":39},"Safety and Adverse Events (AEs)","Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)","Through study completion; an average of 1 year.",[],"ALL","18 Years",null,true,{"inclusion":46,"exclusion":56,"raw_text":66},[47,48,49,50,51,52,53,54,55],"Adults \\> 18 years","Healthy with no malignancy, demyelinating disease, back pain, degenerative disease, or spinal cord lesions.","Consent able patients.","Adults \\> 18 years old.","MR or CSF with evidence of LMD.","Patients to receive CSI as part of standard treatment of LMD disease.","Consent able patients, willingness and ability to comply with the study procedures.","No spinal cord lesions only LMD disease","Recruitment by radiation oncology faculty in consultation with Dr. De. . .",[57,58,59,60,61,62,63,64,65,57,60,61,62,63,64,65],"Age \\\u003C 18 years","Pregnant or breastfeeding individuals.","History of cancer.","History of spinal cord lesions including malignant, demyelinating, or inflammatory.","History of prior spinal surgery.","History of implantable devices.","History of MR claustrophobia.","Degenerative disease or spinal\u002Fback pain including myelopathy and radiculopathy.","Scoliosis.","Inclusion Criteria:\n\nVolunteers:\n\n* Adults \\> 18 years\n* Healthy with no malignancy, demyelinating disease, back pain, degenerative disease, or spinal cord lesions.\n* Consent able patients.\n\nPatients with low volume LMD to receive treatment CNS radiation:\n\n* Adults \\> 18 years old.\n* MR or CSF with evidence of LMD.\n* Patients to receive CSI as part of standard treatment of LMD disease.\n* Consent able patients, willingness and ability to comply with the study procedures.\n* No spinal cord lesions only LMD disease\n* Recruitment by radiation oncology faculty in consultation with Dr. De. . .\n\nExclusion Criteria:\n\nVolunteers:\n\n* Age \\\u003C 18 years\n* Pregnant or breastfeeding individuals.\n* History of cancer.\n* History of spinal cord lesions including malignant, demyelinating, or inflammatory.\n* History of prior spinal surgery.\n* History of implantable devices.\n* History of MR claustrophobia.\n* Degenerative disease or spinal\u002Fback pain including myelopathy and radiculopathy.\n* Scoliosis.\n\nPatients with LMD:\n\n* Age \\\u003C 18 years\n* History of spinal cord lesions including malignant, demyelinating, or inflammatory.\n* History of prior spinal surgery.\n* History of implantable devices.\n* History of MR claustrophobia.\n* Degenerative disease or spinal\u002Fback pain including myelopathy and radiculopathy.\n* Scoliosis.",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"status":7,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":83},"MD Anderson Cancer Center","Houston","Texas","77090","United States",[78],{"name":79,"role":80,"phone":81,"email":82},"Rami Eldaya, MD","CONTACT","713-745-2945","reldaya@mdanderson.org",{"lat":84,"lon":85},29.76328,-95.36327,[87],{"name":79,"role":80,"phone":88,"email":82},"(713) 745-2945",[90],{"name":79,"affiliation":12,"role":91},"PRINCIPAL_INVESTIGATOR",[],[94],{"label":95,"url":96},"MD Anderson Cancer Center Website","http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":98,"biomarkers":101},[99,100],"Healthy","Leptomeningeal Disease",[],{"nct_id":4,"found":44,"summary":103,"prompt_version":113},{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an interventional study with an unclear phase, planning to enroll 13 participants. It is not specified if it is randomized or blinded.","completed","Magnetic Resonance Spectroscopy (MRS) Scan for Spinal Cord Lesions","This study is exploring if a Magnetic Resonance Spectroscopy (MRS) Scan, a special type of MRI, can help doctors understand spinal cord lesions. The study aims to see if MRS can effectively assess these lesions and map the entire spine. Researchers will also test the MRS protocol on a small group of patients with low volume leptomeningeal disease (LMD), a type of cancer that spreads to the membranes around the brain and spinal cord, who are receiving radiation therapy. This will help them understand how radiation affects the spinal cord over time. The study is currently unclear on its recruitment status and plans to enroll 13 participants. The main goal is to check the safety of the MRS scan and any side effects.","Participants will be followed for safety and adverse events through study completion, an average of 1 year.",123,"Participants will receive a Magnetic Resonance Spectroscopy (MRS) Scan. Safety and side effects will be monitored through study completion, which is an average of 1 year.","Not stated in the trial record.",[30],"v2"]