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Trial Title:
FCI in Post-operative Low Grade Gliomas
NCT ID:
NCT06294418
Condition:
Glioma
Conditions: Official terms:
Glioma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Field Cycling Imaging (FCI)
Description:
FCI scan
Arm group label:
Low grade glioma
Summary:
The aim of this pilot study is to explore the utility of a new imaging technique, called
Field Cycling Imaging (FCI), in postoperative low grade gliomas.
The main question it aims to answer is if FCI can differentiate subtypes of low grade
gliomas. Participants will have one FCI scan.
Detailed description:
Standard clinical magnetic resonance imaging (MRI) is the mainstay of diagnosis in brain
lesions. It is a powerful imaging technique for the non-invasive investigation of the
brain and has been an incredibly successful technology since its commercialisation in the
1980s largely due to its excellent spatial resolution and ability to distinguish multiple
tissues in multiple planes. When exogenous contrast agents are used, MRI can demonstrate
the breakdown of the blood-brain barrier and provide additional physiological
information.
However, standard MRI has limitations in determining the subtypes of tumours, which
originate from different cells and therefore contain differing types of proteins. The aim
of this project is to establish if there is a difference in the relaxometry (i.e., loss
of MRI signal over time) characteristics of different brain lesions using Field Cycling
Imaging (FCI), which is a new technology being developed at the University of Aberdeen.
FCI combines the use of a moderately high magnetic field with the ability to probe low
magnetic fields so that one can preserve image resolution while also exploiting the high
contrast present at low magnetic fields. This provides quantitative data on the molecular
dynamics in the tissues, completely non-invasively.
For this study, the research team will use FCI to try to establish if there is a
difference in the relaxometry characteristics of different low-grade gliomas. Ten
patients with postoperative low grade glioma will be included. Each participant will be
asked to undergo one FCI scan only. FCI images will be acquired on dedicated equipment,
specifically built for the purpose of imaging human volunteers and patients. Participants
will carry on receiving their routine clinical care before and after their scan.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with post operative low-grade glioma.
- Capacity to give informed consent.
- Capacity to co-operate with the scanning procedures and duration.
- Age 16 and above.
- Participants who can pass through a 50 cm-diameter circular hoop to ensure they will
be able to fit inside the scanner.
- Participants who meet the safety criteria for undergoing an MRI scan.
- Participants must be mobile enough to be positioned onto the FCI scanner couch.
Exclusion Criteria:
- MRI-incompatible conditions, as detected in the MRI safety screening form.
- Restrictions to mobility that would prevent the correct positioning in the scanner
by trained research radiographer (e.g., severe kyphosis).
- Participants who are unable to give fully informed consent.
- Women who are pregnant.
- Participants who are unable to understand or communicate in English.
- Patients who suffer from claustrophobia.
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aberdeen Royal Infirmary
Address:
City:
Aberdeen
Zip:
AB25 2ZD
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Arnab K Rana, Dr
Phone:
+441224438363
Email:
arnab.rana@abdn.ac.uk
Start date:
February 15, 2024
Completion date:
March 2025
Lead sponsor:
Agency:
NHS Grampian
Agency class:
Other
Collaborator:
Agency:
University of Aberdeen
Agency class:
Other
Source:
NHS Grampian
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06294418