Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05140785 |
| Other study ID # |
288219 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2022 |
| Est. completion date |
May 1, 2027 |
Study information
| Verified date |
February 2022 |
| Source |
King's College Hospital NHS Trust |
| Contact |
Thomas C Booth, PhD |
| Phone |
07977509937 |
| Email |
thomasbooth[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
