Usefulness of Gadovist-enhanced FLAIR Imaging

NCT05293990 | Completed

• 1 other identifier: 2017GR0776
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Malignant Tumors; Brain Lymphoma; CNS Lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by axial FLAIR and axial spin-echo T1-weighted image

  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.

  about 5 year

Study Arms (1)

Contrast-enhanced fluid attenuated inversion recovery

OTHER

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)

Radiation: Usefulness of Gadovist-enhanced FLAIR imaging in differentiation between a glioblastoma and solitary brain metastasis

Interventions

Usefulness of Gadovist-enhanced FLAIR imaging in differentiation between a glioblastoma and solitary brain metastasis RADIATION

Usefulness of Gadovist-enhanced FLAIR imaging in differentiation between a glioblastoma and solitary brain metastasis

Contrast-enhanced fluid attenuated inversion recovery

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ryoo, In Seon: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, Gurogu, 08308, South Korea

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ryoo In Seon, dotorate

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiology

Model Details: For a single malignant mass in the brain, conventional T1 highlighted contrast enhancement findings and histological results (glioblastoma/metastatic brain cancer) were compared and analyzed, followed by diagnosing a single brain mass (Df/Dt1, Dt2/Dt1, Dt2/Df ratio) and histological results.

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 24, 2022
• Study Start: February 2, 2017
• Primary Completion: January 25, 2021
• Study Completion: January 25, 2021
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

KR (1)