Clinical trial · Interventional
Usefulness of Gadovist-enhanced FLAIR Imaging
Usefulness of Gadovist-enhanced FLAIR Imaging in Differentiation Between a Glioblastoma and Solitary Brain Metastasis: Single Center Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Polyplastic glioblastoma and metastatic brain cancer are the most common malignant brain tumors in adults. The primary diagnostic test for tumors in the brain shows magnetic resonance imaging or similar imaging findings (especially single metastatic brain cancer) that make it difficult to distinguish between these two diseases. In addition, due to the specificity of the tissue called the brain, biopsy is not easy and sometimes biopsy is difficult, so non-invasive discrimination is often important, and it is important how much prediction is made before the biopsy. To solve this problem, various advanced magnetic resonance imaging techniques have been studied, but they are all tests that need to be additionally conducted on ordinary magnetic resonance images, and there are many subjective factors, so complex data and statistical processing methods, and many cannot be easily tested. In addition, in all of these tests, accuracy is still reported at around 60%. Therefore, if contrast-enhanced FLAIR images can be obtained along with contrast-enhanced T1 images performed during conventional magnetic resonance imaging tests to help differentiate between two diseases, it will greatly help diagnose and treat brain tumor patients and facilitate clinical application.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Lymphoma | Cerebral Lymphoma | ALIAS | 0.90 |
| CNS Lymphoma | Central Nervous System Lymphoma | ALIAS | 0.90 |
| Malignant Tumors | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Usefulness of Gadovist-enhanced FLAIR imaging in differentiation between a glioblastoma and solitary brain metastasis | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Contrast-enhanced fluid attenuated inversion recovery
- description
- Confirmation of the difference between FLAIR contrast enhancement and T1 contrast enhancement patterns--\>PACS monitor shows the maximum dimension of FLAIR and T1 contrast enhancement by two neurology radiologists on FLAIR and T1 contrast enhancement images. In addition, the maximum diameter of the T2 high-signal lesion around the tumor is obtained using FLAIR images before contrast in the same plane. (Dt2)
- interventionNames
- Radiation: Usefulness of Gadovist-enhanced FLAIR imaging in differentiation between a glioblastoma and solitary brain metastasis
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by axial FLAIR and axial spin-echo T1-weighted image
- timeFrame
- about 5 year
- description
- Two 3.0 Tesla MR machines (MAGNETOM Trio A Tim and MAGNETOM Prisma; Siemens, Erlangen, Germany) were used in this study. The protocol consisted of axial FLAIR (TR/TE/TI=9,000/100/2,500 milliseconds, with slice thickness of 2 mm) and axial spin-echo T1-weighted image (TR/TE=675/8.9 milliseconds, with slice thickness of 2 mm). After both pre-enhancement images are acquired, CE-T1WI and CE-FLAIR sequences were obtained 5 and 10 minutes after administering gadolinium-based contrast agents, respectively. Gadobutrol (Gadovist™, 0.1 millimol per kilogram of body weight, Schering AG, Berlin, Germany) was used as the contrast agent, via automated injector (Spectris MR; Medrad Europe, Maastricht, Netherlands). Subtraction images for both CE-FLAIR and CE-T1WI sequences were also obtained. Detailed protocol image sequence parameter is provided in shown in Online Resource 2.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * All patients who undergo treatment, including surgery, after examining contrast-enhanced MR with an intra-brain mass that must exclude malignant tumors. * Adults over 19 years of age at the time of examination * Patients who agreed to this clinical study Exclusion Criteria: * In the case of severe cognitive of dysfunction or neurological defects (mRS\>3) * Pregnant or lactating patient * Patients who are allergic to MRI contrast agents or cannot perform MRI for other reasons. * Patients participating in other drug clinical trials as of the screening day (observation studies are possible)
References
Publications (0)
Data not yet available