Intracranial Neoplasm Clinical Trial
Official title:
Evaluation of Regional Gadolinium Retention in the Brain Using QSM With Correlation to Regional DCE MRI Permeability Using GOCART Technique in Intracranial Neoplasm Patients Receiving Gadobenate Dimeglumine (MultiHance) or Gadoterate Meglumine (Dotarem)
This randomized pilot clinical trial studies quantitative susceptibility mapping (QSM) and regional dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) permeability using golden-angle cartesian randomized time-resolved (GOCART) technique in evaluating regional gadolinium retention in the brain in patients with intracranial neoplasm receiving gadobenate dimeglumine or gadoterate meglumine. MRI diagnostic techniques such as, QSM and DCE MRI, may help to gather information regarding brain changes associated with gadolinium deposits during 8 to 18 months after administration of gadobenate dimeglumine or gadoterate meglumine.
PRIMARY OBJECTIVES: I. To obtain preliminary data (e.g. mean, variance, distribution) in the regional brain parenchymal changes associated with gadolinium (Gd) deposition during 8 to 18 months period after administration of gadolinium based contrast agents (GBCA) to Gd naive intracranial neoplasm patients who will be randomized to gadobenate dimeglumine (MultiHance) or gadoterate meglumine (Dotarem). II. To explore if areas of increased regional Gd deposition at individual level are correlated with baseline regional DCE permeability metrics such as volume transfer coefficient reflecting vascular permeability (kTrans), extracellular volume ratio reflecting vascular permeability (ve) and plasma volume (vp) in intracranial neoplasm patients. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo standard of care QSM and T1 weighted imaging (T1WI). Patients then receive gadobenate dimeglumine intravenously (IV) and undergo GOCART DCE MRI over 60 minutes. ARM II: Patients undergo standard of care QSM and T1WI. Patients then receive gadoterate meglumine IV and undergo GOCART DCE MRI over 60 minutes. After completion of study, patients are followed up at 8-18 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05732896 -
Comparison of Opioid Consumption During TCI Guided by NOL Index or Standard Care Undergoing Intracranial Tumor Surgery
|
N/A | |
| Active, not recruiting |
NCT04044937 -
Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms
|
Phase 2 | |
| Not yet recruiting |
NCT03717766 -
Application of New Technologies in the Resection of Intracranial Tumors
|
||
| Completed |
NCT05145049 -
The Relationship of Anesthesia Method With Serum Lactate Level in Craniotomies
|
||
| Terminated |
NCT03089749 -
Characterization of Human Autoantibody Titers After Central Nervous System Insult
|
||
| Not yet recruiting |
NCT05891002 -
Accuracy of Robotically Assisted Cranial Biopsies
|
||
| Recruiting |
NCT06291662 -
Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing
|
N/A | |
| Completed |
NCT04302857 -
Tractography Pilot Study Leipzig
|
||
| Completed |
NCT04454268 -
Intracranial Hydatid Cyst
|
N/A | |
| Completed |
NCT03076255 -
Head and Neck Maskless Immobilization Device in Immobilizing Patients With Head and Neck Cancer or Intracranial Tumors Undergoing Radiation Therapy
|
N/A | |
| Recruiting |
NCT04278118 -
Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study
|
N/A | |
| Recruiting |
NCT03714347 -
The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery
|
N/A | |
| Completed |
NCT03710278 -
The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)
|
||
| Completed |
NCT03539731 -
[18F]DASA-23 and PET Scan in Evaluating Pyruvate Kinase M2 Expression in Patients With Intracranial Tumors or Recurrent Glioblastoma and Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT05904704 -
Oxygen-Enhanced MRI for Generating Hypoxia Maps in Patients With Intracranial Tumors
|
N/A |