FCI in Post-operative Low Grade Gliomas

March 4, 2024 updated by: NHS Grampian

Non-invasive In-vivo Characterisation of Postoperative Low Grade Gliomas Using Field Cycling Imaging (FCI)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low grade glioma
Patients with postoperative low grade glioma will undergo one FCI scan.
Device: Field Cycling Imaging (FCI)
FCI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differentiation of sub-types of low grade glioma assessed by Field Cycling Imaging (FCI) T1 dispersion profiles
Time Frame: At baseline
Validation of FCI T1 dispersion profiles as a non-invasive technology to differentiate sub-types of low grade glioma.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Grampian

Collaborators

University of Aberdeen

Investigators

  • Study Chair: Arnab K Rana, Dr, University of Aberdeen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-037-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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