Mapping Molecular Markers of Brain Tumour Activity Using MRI
In Vivo Molecular Mapping of Adult Primary Brain Tumour Activity Using Novel Magnetic Resonance Imaging (MRI): a Pilot Study
1 other identifier
interventional
30
1 country
1
Brief Summary
Regions of tumour whose cells (the building blocks of the tumour) are actively multiplying generate a particular type of molecular footprint (consisting of various types of proteins) compared to tumours whose cells are relatively stable. In addition, tumour cells begin to develop a network of blood vessels that not only supply them with nutrients and oxygen, but also provide a pathway for tumour spread. There is a critical period between when these proteins and blood vessel network develops, and when tumour growth is visible using current MRI scanning. Therefore, making the process of tumour activity visible on clinical MRI scans is an important step in demonstrating and anticipating tumour growth. The study aims to do this by utilising various novel and non-invasive MRI techniques. This project is a collaboration between research groups at King's College London (UK) and the Erasmus University Rotterdam (The Netherlands). The novel MRI techniques will be incorporated into the pre-surgical imaging protocol of patients with primary brain tumours. The images will be compared with molecular measurements made from biopsies taken during surgery to show that they accurately map where activity is high and low within the tumour.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
December 1, 2021
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
March 9, 2022
February 1, 2022
5 years
November 10, 2021
February 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation of the MRI signal intensity (advanced MRI sequence 1; arbitrary units) and glioma protein concentration (g/L) in a 1 x 1 x 1 cm region of interest (R value)
MRI signal will be recorded from different regions of interest within a glioma where stereotactic surgical biopsies taken and protein concentration determined.
5 years
Secondary Outcomes (1)
Correlation of the MRI signal intensity (advanced MRI sequence 2; arbitrary units) and glioma metabolite concentration (g/L) in a 1 x 1 x 1 cm (R value)
5 years
Study Arms (1)
Brain tumour patients
EXPERIMENTALPatients will be those undergoing routine care of primary brain tumours. Study group patients will undergo additional MRI sequences and biopsies in addition to the standard of care.
Interventions
Advanced MRI sequences which look to a) determine structure of a primary brain tumour and b) metabolism within a primary brain tumour
Eligibility Criteria
You may qualify if:
- Individuals of 18 years or older
- Referred for surgery (resection or biopsy) of primary brain tumour
- Written informed consent
You may not qualify if:
- Contra-indication for MRI contrast
- Inability to give consent
- Have received/are receiving chemotherapy at time of MRI
- Patient is pregnant or planning to become pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Hospital NHS Trustlead
- Erasmus Medical Centercollaborator
- King's College Londoncollaborator
Study Sites (1)
King's R&I department
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas C Booth, PhD
King's College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Investigator and Consultant Diagnostic and Interventional Neuroradiologist, Department of Neuroradiology, Ruskin Wing, King's College Hospital NHS Foundation Trust, London. SE5 9RS
Study Record Dates
First Submitted
November 10, 2021
First Posted
December 1, 2021
Study Start
May 1, 2022
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
March 9, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share