Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 3:07 PM
Study NCT ID:
NCT07415018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008577', 'term': 'Meningeal Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'C000656634', 'term': 'gadopiclenol'}, {'id': 'C090600', 'term': 'gadobutrol'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-01-22', 'size': 173315, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-02-13T12:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and adverse events (AEs)', 'timeFrame': 'Through study completion; an average of 1 year.', 'description': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leptomeningeal Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To learn if gadopiclenol (a contrast agent) used during MRI scanning can help in the detection of early LMD.', 'detailedDescription': '* Primary Objectives Primary Aim: Establish the ability of VUEWAY® (gadopiclenol) to detect early CNS LMD in brain MR while optimizing the ideal scan parameters including dose, sequences, and optimal timing for detection of CNS LMD in brain MRI. Brain MR offers a noninvasive alternative/complementary method to CNS sampling for detection of LMD. However, sensitivity for disease detection remains acceptable at best ranging from 33% in hematological malignancies in some studies to 75% (7, 8). This limits detection of early LMD thus potentially delaying diagnosis and initiation of life-saving treatment. We hypothesize that the excellent relaxivity of VUEWAY® (gadopiclenol) coupled with its safety profile including lower dosage compared to other contrast agents can be utilized to optimize an LMD specific MR brain protocol to improve MR ability to detect early LMD disease.\n* Secondary Objectives Secondary Aim: Establish the ideal protocol and dose of VUEWAY® (gadopiclenol) for the detection of parenchymal brain metastatic disease. Brain MRI is the primary modality for detection and screening of intracranial metastasis. Brain MRI detects metastasis in 70% of participants that are asymptomatic at the time of diagnosis (9). However, sensitivity of MR for detection of smaller metastasis depends on acquisition sequences, dose of contrast, and timing of scanning after contrast administration (10-12). We hypothesize that the excellent relaxivity of VUEWAY® (gadopiclenol) coupled with its safety profile including lower dosage compared to other contrast agents can be utilized to increase detection of smaller parenchymal metastatic lesions on brain MR exams. Furthermore, in addition to serving as aim 2 for this study, this will serve as an internal control for quality assessment for aim 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with tissue confirmed solid malignancy and brain MRI with equivocal results for LMD (questionable or possible) and negative LP CSF sampling or participants with high risk clinical LMD and negative brain MR and LP CSF sampling. Initially, we will target solid tumors, but if more participants are needed to meet the study power we will enroll liquid tumors.\n* Participants \\> 18 years of age.\n* Participants are able to consent.\n\nExclusion Criteria:\n\n* Participants with CSF sampling positive for LMD or MR brain/spine with definitive evidence of LMD.\n* Participants with implantable devices that can not be scanned with MR safe mode for participant safety.\n* Pregnant participants or potentially pregnant participants are at risk of contrast on the fetus\n\nPediatric participants \\< 18 years of age.'}, 'identificationModule': {'nctId': 'NCT07415018', 'briefTitle': 'Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease', 'orgStudyIdInfo': {'id': '2025-1395'}, 'secondaryIdInfos': [{'id': 'NCI-2026-00997', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MRI Scan with Gadavist (gadobutrol) / VUEWAY (gadopiclenol)', 'description': 'Participants found to be eligible to take part in this study and agree to take part, will have brain MRI scans as part of standard of care. Then, within a week (preferably within 48 hours) of the participants routine brain MRI scans, you will have LMD-focused brain MRI scans with gadopiclenol contrast. Specifically, MRI scans will be done immediately after a small amount of gadopiclenol is given through an IV catheter placed into a vein, and then at 10 and 30 minutes thereafter. Then, a second dose of gadopiclenol will be given, and MRI scans will be done immediately after. The MRI scans performed for research purposes will take approximately 50 minutes to complete. You will be followed by routing clinical and imaging guidelines for 6 months or until the confirmation of LMD (whichever comes first).', 'interventionNames': ['Procedure: MRI Scan', 'Drug: VUEWAY', 'Drug: Gadavist']}], 'interventions': [{'name': 'MRI Scan', 'type': 'PROCEDURE', 'description': 'Given during standard of care', 'armGroupLabels': ['MRI Scan with Gadavist (gadobutrol) / VUEWAY (gadopiclenol)']}, {'name': 'VUEWAY', 'type': 'DRUG', 'otherNames': ['gadopiclenol'], 'description': 'Given by IV', 'armGroupLabels': ['MRI Scan with Gadavist (gadobutrol) / VUEWAY (gadopiclenol)']}, {'name': 'Gadavist', 'type': 'DRUG', 'otherNames': ['gadobutrol'], 'description': 'Given by IV', 'armGroupLabels': ['MRI Scan with Gadavist (gadobutrol) / VUEWAY (gadopiclenol)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Rami Eldaya, MD', 'role': 'CONTACT', 'email': 'reldaya@mdanderson.org', 'phone': '713-745-2945'}, {'name': 'Rami Eldaya, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Rami Eldaya, MD', 'role': 'CONTACT', 'email': 'reldaya@mdanderson.org', 'phone': '(713) 745-2945'}], 'overallOfficials': [{'name': 'Rami Eldaya, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}