Safety of Ferumoxytol as a Contrast Agent for MRI in Humans with MS

study design"studyType": "INTERVENTIONAL"

subjects"eligibilityCriteria": "* INCLUSION CRITERIA:\n\nHEALTHY VOLUNTEER INCLUSION CRITERIA\n\n* age between 18 and 70 (inclusive)\n* able to give informed consent\n* brain MRI within 2 years of study enrollment that shows no clinically significant abnormalities, in the judgment of a board-certified and NIH-credentialed neuroradiologist\n\nPATIENT INCLUSION CRITERIA\n\n* age between 18 and 70, inclusive\n* able to give informed consent\n* diagnosis of multiple sclerosis according to revised McDonald Criteria\n\nEXCLUSION CRITERIA:\n\nGENERAL EXCLUSION CRITERIA:\n\n* screening labs demonstrating any value for hepatic or renal function levels out of the range of normal, to include AST, ALT, bilirubin, alkaline phosphatase, creatinine, eGFR\n* evidence of polycythemia vera with hemoglobin levels more than 1 standard deviation above the NIH laboratory s normal level\n* iron overload syndromes, including hemochromatosis, or subjects with evidence of iron overload with a baseline ferritin level greater than 370 ng/ml and percent saturation of transferrin level greater than 40%.\n* previous or current alcohol and/or substance abuse per medical history or medical records\n* medical contraindications for MRI (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects, or body piercings that are not MRI-compatible or cannot be removed)\n* psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the time the medical history is collected\n* pregnancy or current breastfeeding\n* reported history of clinically significant impaired hearing, because people with impaired hearing are at increased risk of sound-induced damage from the MRI scanner\n* known allergy to dextran or drugs containing iron salts or any previous history of severe allergic reactions, anaphylaxis, to any drug\n* clinically significant medical or neurological disorders that, in the judgment of the investigators might expose the patient to undue risk of harm confound study outcomes or prevent the participant from completing the study; examples of such conditions include but are not limited to diagnosis of certain types of cancer, cardiopulmonary conditions such as congestive heart failure, or uncontrolled hypertension\n\nADDITIONAL PATIENT EXCLUSION CRITERION:\n\n-4 or more gadolinium-enhancing lesions on the screening scan",

species"eligibilityCriteria": "* INCLUSION CRITERIA:\n\nHEALTHY VOLUNTEER INCLUSION CRITERIA\n\n* age between 18 and 70 (inclusive)\n* able to give informed consent\n* brain MRI within 2 years of study enrollment that shows no clinically significant abnormalities, in the judgment of a board-certified and NIH-credentialed neuroradiologist\n\nPATIENT INCLUSION CRITERIA\n\n* age between 18 and 70, inclusive\n* able to give informed consent\n* diagnosis of multiple sclerosis according to revised McDonald Criteria\n\nEXCLUSION CRITERIA:\n\nGENERAL EXCLUSION CRITERIA:\n\n* screening labs demonstrating any value for hepatic or renal function levels out of the range of normal, to include AST, ALT, bilirubin, alkaline phosphatase, creatinine, eGFR\n* evidence of polycythemia vera with hemoglobin levels more than 1 standard deviation above the NIH laboratory s normal level\n* iron overload syndromes, including hemochromatosis, or subjects with evidence of iron overload with a baseline ferritin level greater than 370 ng/ml and percent saturation of transferrin level greater than 40%.\n* previous or current alcohol and/or substance abuse per medical history or medical records\n* medical contraindications for MRI (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects, or body piercings that are not MRI-compatible or cannot be removed)\n* psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the time the medical history is collected\n* pregnancy or current breastfeeding\n* reported history of clinically significant impaired hearing, because people with impaired hearing are at increased risk of sound-induced damage from the MRI scanner\n* known allergy to dextran or drugs containing iron salts or any previous history of severe allergic reactions, anaphylaxis, to any drug\n* clinically significant medical or neurological disorders that, in the judgment of the investigators might expose the patient to undue risk of harm confound study outcomes or prevent the participant from completing the study; examples of such conditions include but are not limited to diagnosis of certain types of cancer, cardiopulmonary conditions such as congestive heart failure, or uncontrolled hypertension\n\nADDITIONAL PATIENT EXCLUSION CRITERION:\n\n-4 or more gadolinium-enhancing lesions on the screening scan",

sample size"count": 14

sample size basis"type": "ACTUAL"

randomized"allocation": "NA"

controlled"allocation": "NA"

peer reviewed"isFdaRegulatedDrug": true

regulatory approval"isFdaRegulatedDrug": true

regulatory approval details"detailedDescription": "Objective\n\nThe goals of this pilot study are to (1) demonstrate the safety of ferumoxytol, a United States Food and Drug Administration (FDA) approved drug used in the treatment of iron deficiency anemia, as a contrast agent for brain magnetic resonance imaging (MRI), as determined by a lack of long-term signal change in healthy volunteers (HV) and people with multiple sclerosis (MS); (2) determine if ferumoxytol enhancement can be detected in MS lesions on 7-tesla (T) MRI; and (3) examine the spatial and temporal enhancement patterns of ferumoxytol compared to patterns seen with gradient-echo imaging and gadolinium contrast in MS lesions.\n\nStudy population\n\nUp to 10 HVs and up to 10 participants with MS will be recruited for this study.\n\nDesign\n\nParticipants will undergo a series of brain MRIs on a 7 T scanner.

intervention"name": "Ferumoxytol"

primary endpoint"measure": "change in gradient-echo T2*-weighted signal in an iron-rich brain structure, the globus pallidus"

follow up"timeFrame": "6 months following ferumoxytol administration"

findingsThey want to determine that it does not cause prolonged MRI changes in the brain and to see if it helps identify inflammation in multiple sclerosis\n\nObjective:\n\n\\- To learn how ferumoxytol can be used to image inflammation in multiple sclerosis (MS).\n\nEligibility:\n\n* Adults ages 18 70 who have MS.\n* Healthy volunteers ages 18 70.\n\nDesign:\n\n* Participants will have 5 clinic visits over 6 months.\n* Participants will be screened with a medical history, neurological exam, and blood draw.

limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.