Clinical trial · Observational
Comparison of Contrast Agents for MRI Perfusion Analysis in Brain Tumor Patients
Gadobenate Dimeglumine Compared to Gadobutrol for MRI Perfusion Analysis in Brain Tumor Patients
NCT02095353CI-TRIAL-00069009terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): FDA safety concerns with repeated use of gadolinium-based contrast; subjects received additional dose of contrast with no direct clinical benefit
Summary
Brief summary (as posted)
This study will compare the use of two contrast agents to analyze blood flow characteristics of brain tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Neoplasms | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Degree of contrast induced signal changes with dynamic imaging of brain tumors
- timeFrame
- 2 weeks
- description
- Two contrast agents will be administered in different MRI imaging sessions. Will measure how the appearance of brain tumors change during dynamic first pass contrast administration.
Secondary outcomes (1)
- measure
- Calculate differences in cerebral blood volume, ktrans and flow in brain tumors
- timeFrame
- 2 weeks
- description
- Calculations will be made of cerebral blood volume, cerebral blood flow or ktrans in brain tumors when different contrast agents are administered. These parameters reflect vasculature and angiogenesis in tumors.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with brain tumors will be enrolled. These subjects may be newly diagnosed, undergoing treatment or undergoing follow-up. If a subject has undergone surgery or treatment they should have what appears to be residual tumor. Exclusion Criteria: * Renal failure (GFR \<45). Subjects will be screened utilizing UNMC gadolinium contrast guidelines. * Allergic reactions to MRI contrast agents. * Subjects who do not fit the criteria for the population we are evaluating. * Subjects should not participate in this study if they have any of the following conditions: * Anxiety attacks * Panic disorder * Claustrophobia * Pregnant, or trying to become pregnant * Breast feeding * Subjects should not participate in this study if they have certain kinds of metal in their body, for example: a heart pacemaker, defibrillator, neurostimulator, a metal plate, certain otologic implants, certain types of heart valves, metal slivers in eye, brain aneurysm clips or metal slivers and bullet fragments in or near certain structures in their body. Our standard MRI safety screening will be performed on all subjects. * If a subject has metal in their body that requires an additional x-ray beyond what is needed for the clinical MRI examination to safely perform the research MRI examination that subject would be excluded.Subjects not being able to return for a follow-up examination
References
Publications (0)
Data not yet available
No reference posted for this study.