protocolSection identificationModule nctId: NCT06322342, orgStudyIdInfo id: RVL-102-23, secondaryIdInfos id: 9R44CA261240-04A1, type: NIH, link: https://reporter.nih.gov/quickSearch/9R44CA261240-04A1, briefTitle: Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Reveal Pharmaceuticals Inc., class: INDUSTRY, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: The Phase 2 trial will assess safety, tolerability, efficacy, imaging pharmacodynamics, and pharmacokinetics of RVP-001, a novel manganese-based MRI contrast agent, at three escalating dose levels when administered as a single IV bolus to subjects with known gadolinium-enhancing central nervous system (CNS) lesions who have recently had a gadolinium-based contrast agent (GBCA)-enhanced MRI of the brain., conditionsModule conditions: Central Nervous System (CNS) Lesions, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: RVP-001, outcomesModule primaryOutcomes measure: Adverse Events, primaryOutcomes measure: Lesion visualization criteria for RVP-001 enhanced MRI compared to unenhanced MRI, primaryOutcomes measure: Lesion visualization criteria for RVP-001 compared to gadolinium-based contrast agent (GBCA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yale New Haven Hospital, status: NOT_YET_RECRUITING, city: New Haven, state: Connecticut, zip: 06510, country: United States, contacts name: Kristin DeFancesco, role: CONTACT, phone: 203-785-3852, email: kristin.defrancesco@yale.edu, contacts name: Amit Mahajan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Abi Akinniyi, role: CONTACT, phone: 781-513-0207, email: aakinniyi@mgb.org, contacts name: John Chen, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Brigham & Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Cora Nicoll, role: CONTACT, phone: 617-525-3161, email: cnicoll1@bwh.harvard.edu, contacts name: Mathew DeSalvo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Duke University Medical Center, status: RECRUITING, city: Durham, state: North Carolina, zip: 27710, country: United States, contacts name: Helen Zuleta, role: CONTACT, phone: 919-613-0226, email: helen.zuleta@duke.edu, contacts name: Shruti Raja, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False