GliomaNCT05140785
Mapping Molecular Markers of Brain Tumour Activity Using MRI
A study testing Advanced MRI sequences in people with Glioma, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Advanced MRI sequences
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2022to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals of 18 years or older
- Referred for surgery (resection or biopsy) of primary brain tumour
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: In Vivo Molecular Mapping of Adult Primary Brain Tumour Activity Using Novel Magnetic Resonance Imaging (MRI): a Pilot Study
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.
Read the detailed description
Patients recruited into this study will be those for whom a surgical resection or biopsy of a primary brain tumour has already been planned by the King's College Hospital Neuro-oncology team. All patients in the UK arm of this international study will be recruited at the King's College Hospital site. Research imaging performed on patients enrolled in this study will take place at the Guy's and St Thomas' Hospital site.
For patients who have consented to be included in our research study, novel MRI techniques will be included in addition to the standard primary brain tumour imaging protocol, to provide additional information about the nature of the primary tumour: for example, the structural components and metabolism.
The MRI scan will last approximately 60 minutes, which is approximately 30 minutes longer than the standard brain tumour biopsy protocol. Further MRI scans will be performed after surgery and, if necessary, at recurrence (up to a maximum of three scans per patient) to look at advanced imaging changes at each time-point alongside structural changes. These additional scans should also last a maximum of 60 minutes.
All patients will undergo surgery for biopsy/resection of the tumour as part of the standard of care. All routine surgical procedures, pre-surgical and post-surgical care will take place predominantly at King's College Hospital site. Before craniotomy takes place for tumour resection, the neurosurgeon will take 3 tissue samples of the tumour. This will occur via stereotactic (computer-guided) biopsies. A needle will be guided through to a location of interest determined by the novel MRI techniques. This should result in an extension of the surgery time of approximately 30 minutes (10 minutes per biopsy), in addition to the approximately 4 hours needed for the surgery.
After removal, each biopsy specimen is put into a suitable container for preservation. The container will be de-identified and shipped to the Department of Pathology, Erasmus University Rotterdam, The Netherlands where the specimen will be securely stored.
The samples will be cut and slide-mounted for staining. When looking at the specimen under a microscope, particular features which suggest how aggressive the tumour is will be looked for. Information gathered from the tissue biopsies will then be compared and matched to information on the original MRI scan to see whether the novel images obtained can accurately predict the aggressiveness of different parts of the tumour.
- Conditions
- Glioma
- Being tested
- Advanced MRI sequences
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced MRI sequencesDiagnostic test
Advanced MRI sequences which look to a) determine structure of a primary brain tumour and b) metabolism within a primary brain tumour
| Study group | Role | What they receive |
|---|---|---|
| Brain tumour patients | Experimental | Patients 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. Receives: Diagnostic Test: Advanced MRI sequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
MRI signal will be recorded from different regions of interest within a glioma where stereotactic surgical biopsies taken and metabolite concentration determined.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 May 2022 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, King's College London
- Responsible party
- Principal investigator, Thomas Booth, King's College Hospital NHS Trust
- Investigators
- Thomas C Booth, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140785
- Sponsor's protocol ID
- 288219
- Status last verified
- Feb 2022
- First submitted
- 10 Nov 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Molecular Mapping of Adult Primary Brain Tumour Activity Using Novel Magnetic Resonance Imaging (MRI): a Pilot Study
- ClinicalTrials.gov ID
- NCT05140785
- Acronym / sponsor ID
- 288219
- Conditions
- Glioma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, King's College London
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients recruited into this study will be those for whom a surgical resection or biopsy of a primary brain tumour has already been planned by the King's College Hospital Neuro-oncology team. All patients in the UK arm of this international study will be recruited at the King's College Hospital site. Research imaging performed on patients enrolled in this study will take place at the Guy's and St Thomas' Hospital site.
For patients who have consented to be included in our research study, novel MRI techniques will be included in addition to the standard primary brain tumour imaging protocol, to provide additional information about the nature of the primary tumour: for example, the structural components and metabolism.
The MRI scan will last approximately 60 minutes, which is approximately 30 minutes longer than the standard brain tumour biopsy protocol. Further MRI scans will be performed after surgery and, if necessary, at recurrence (up to a maximum of three scans per patient) to look at advanced imaging changes at each time-point alongside structural changes. These additional scans should also last a maximum of 60 minutes.
All patients will undergo surgery for biopsy/resection of the tumour as part of the standard of care. All routine surgical procedures, pre-surgical and post-surgical care will take place predominantly at King's College Hospital site. Before craniotomy takes place for tumour resection, the neurosurgeon will take 3 tissue samples of the tumour. This will occur via stereotactic (computer-guided) biopsies. A needle will be guided through to a location of interest determined by the novel MRI techniques. This should result in an extension of the surgery time of approximately 30 minutes (10 minutes per biopsy), in addition to the approximately 4 hours needed for the surgery.
After removal, each biopsy specimen is put into a suitable container for preservation. The container will be de-identified and shipped to the Department of Pathology, Erasmus University Rotterdam, The Netherlands where the specimen will be securely stored.
The samples will be cut and slide-mounted for staining. When looking at the specimen under a microscope, particular features which suggest how aggressive the tumour is will be looked for. Information gathered from the tissue biopsies will then be compared and matched to information on the original MRI scan to see whether the novel images obtained can accurately predict the aggressiveness of different parts of the tumour.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain tumour patients | Experimental | Diagnostic Test: Advanced MRI sequencesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals of 18 years or older
- Referred for surgery (resection or biopsy) of primary brain tumour
- Written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced MRI sequencesAdvanced MRI sequences which look to a) determine structure of a primary brain tumour and b) metabolism within a primary brain tumour | Diagnostic test | Brain tumour patients |
Primary outcome
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)
Time frame: 5 years
MRI signal will be recorded from different regions of interest within a glioma where stereotactic surgical biopsies taken and protein concentration determined.
1 secondary outcome
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)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas C Booth, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced MRI sequences in people with Glioma, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas C Booth, PhD (07977509937, thomasbooth@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.