Clinical trial NCT06294418: FCI in Post-operative Low Grade Gliomas
Official title: Non-invasive In-vivo Characterisation of Postoperative Low Grade Gliomas Using Field Cycling Imaging (FCI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioma
Lead sponsor: NHS Grampian
Sponsor class: OTHER_GOV
Collaborators: name: University of Aberdeen
First posted: 2024-03-05
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Primary outcomes:
measure: Differentiation of sub-types of low grade glioma assessed by Field Cycling Imaging (FCI) T1 dispersion profiles
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
Study officials:
affiliation: University of Aberdeen
name: Arnab K Rana, Dr
role: STUDY_CHAIR
References: