Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
NCT ID:
NCT04097535
Group ID:
EG000
Title:
Patients With a Suspected Cerebral Glioma on Standard of Care MRI
Description:
Participants was a suspected cerebral glioma on standard of care imaging that are enrolled into the study had an \[18F\]FPIA PET-MRI scan performed at Imanova Limited on a Signa™ 3.0 T scanner.
All participants enrolled into the study subsequently underwent a biopsy or surgical resection as part of their routine clinical care. Tissue obtained post-procedure (surgical resection/biopsy) to determine tumour grade and perform metabolomics, genomics, and proteomics.
PET-MRI Protocol: Subjects received a single I.V bolus injection of \[18F\]FPIA followed by a saline flush. A single dose of \[18F\]FPIA (maximum 370MBq) was administered followed by a whole brain dynamic PET-MRI scan over 66 minutes. During the MRI sequences, the patients received an additional I.V bolus of Gadolinium contrast-medium administered through a peripheral venous cannula.
MRI: Sequences for attenuation correction of PET data (DIXON, zero-TE), volumetric T1-weighted images (pre- and post-contrast administration), volumetric T2, dynamic susceptibility contrast perfusion (DSC) and dynamic contrast enhanced perfusion (DCE).
* Maximum Injected Activity: 370MBq
* Conversion Factor (mSv/MBq): 0.0187
* Total Effective Dose (mSv)/patient: 6.9 mSv
The total effective dose for each patient in this study is 6.9 mSv. There is no ionising radiation from the MR component of the study.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
10
Other Number Affected:
0
Other Number At Risk:
10
Study:
NCT04097535
Results Section:
NCT04097535
Adverse Events Module:
NCT04097535