At Barking, Havering and Redbridge University Hospitals NHS Trust (BHRUT) we have a busy Neurosurgery Department. We treat thousands of patients a year in our outpatient clinics and inpatient wards. Our aim is for each patient to be offered the opportunity to participate in clinical trials. We believe clinical trials are essential to learn more about diseases, develop better treatments for them and empowering our patients and staff to make a real difference in the way the NHS treats patients. There is also strong research showing that clinical trials benefit all patients, even those not directly participating in them, by improving the general standard of care that comes with closer scrutiny of medical records and patient interactions. Furthermore, we believe patients should not have to travel long distances to access the benefits of clinical trials and would like to offer as many trials as possible as your local Neurosciences unit.

Please feel free to ask about the current trials we offer below, and our upcoming trials in the setup phase.

Open to recruitment

The majority of patients who suffer a traumatic brain injury (TBI) do not need to stay in hospital overnight. However, some require admission to a specialist hospital, as their injury is more serious. Seizures can be harmful or even fatal, if not treated appropriately. Medications that reduce the risk of seizures are called antiepileptic drugs (AEDs). However, AEDs have side effects, which can affect patients’ quality of life, memory, concentration and general health.

Patients with seizures after TBI are typically prescribed an AED to prevent further seizures, most commonly Phenytoin or Levetiracetam. Some doctors favour a short course, whereas others favour a longer course. The first part of the trial aims to answer if one approach is better than the other (MAST-duration). The second part of the trial aims to answer if a 7-day course of either Phenytoin or Levetiracetam should be used for patients with a serious TBI to prevent seizures from happening (MAST- prophylaxis).

All patients admitted to a neurosurgical unit within the UK, with a serious TBI, will be considered for the trial. Patients who have been started on either Phenytoin or Levetiracteam by their clinical team due to seizures will be randomised to either up to 3 months or at least 6 months of treatment. In an independent, parallel trial, TBI patients who have not had a seizure will be randomised to phenytoin, levetiracetam or no treatment. All patients will be managed as per usual NHS practice and followed up for 24 months. The main outcome measure will be the occurrence of seizures following TBI at 2 weeks in the MAST- prophylaxis trial and at 24 months in the MAST-duration trial. Finally we will be using several questionnaires to measure frequency of seizures, adverse events, neurological symptoms, quality of life, independence and disability. 

Functional and Ultrasound guided Resection of Glioblastoma. A two-stage trial. Stage 1 – Non-randomised collaborative learning and evaluation phase of participating centres (IDEAL Stage 2b study), followed by Stage 2 – A Multicentre Phase III trial with 2 mechanistic sub studies.

This project asks: What is the best technology a surgeon can use to remove as much brain cancer as possible, whilst minimising risk of damage to brain function and improving patient quality of life?

For patients with a brain tumour called Glioblastoma (GB) prolonging survival whilst ensuring quality of life are key, but remain challenging. GB is incurable and the most frequent and aggressive form of brain cancer, with an extremely poor prognosis both in quality and length of life.

Patients experience a decline in Health-Related Quality of Life (HRQoL), and caregivers report high levels of distress and carer burden. The main treatments for GB are surgery, radiotherapy, and chemotherapy, used in various combinations. For patients where it is thought that surgery will benefit, a surgeon often removes as much as possible, whilst limiting the risk of causing problems, such as, weakness, speech or cognitive difficulties. However, it is unclear as to which techniques a surgeon should use to remove the tumour safely. This influences when the cancer returns, what symptoms the patient has, and how a patient feels.

Ultrasound (US) (high frequency sound waves which create an image) is one of the tools a surgeon can use during the operation to find the tumour and assess how much is being removed during the operation. Another technique, Diffusion Tensor Imaging (DTI) allows important fibres involved in specific functions, for example, speech/language, vision, and movement to be seen during surgery. This means that potential damage to these functions might be avoided during the procedure.

This study aims to see if surgery to remove a GB with additional imaging added to present standard techniques improves HRQoL. This will be assessed through participants and their proxies completing HRQoL questionnaires before and after surgery for up to 2 years.

Prospective Evaluation of AI R&D tool for Biology and Response in Adult Invasive Neuro-oncology

Brain tumours are the leading cause of cancer death in the under 40's, and there has been little progress in the last 15 years. Pear Bio have developed a diagnostic test that may help oncologists decide on the appropriate course of treatment for patients with cancer. The diagnostic test uses a small tumour sample taken from the patient, alongside a blood sample. Samples are placed in a 3D hydrogel to create microtumours, which act as a proxy for the patient to test treatment options in a laboratory without exposing the actual patient to those treatments. Various approved treatment options are tested in parallel microtumours at Pear Bio's central laboratory. A report is generated on which treatments work best on a given patient's tumour sample, so their oncologist can prescribe an effective treatment. As Pear Bio's technology is still in early development for brain tumours, this study will serve to validate the technology. Tumour and blood samples are taken from patients during standard-of-care surgery and used to optimise Pear Bio's Full Set of technology to test therapies used in the UK or the USA to treat brain cancers.

This study will enable future studies that are used to guide treatment decisions between multiple approved treatment options on a personalised basis. Outside of sample collection during surgery, this is a laboratory-based study designed to optimise various aspects of Pear Bio's technology for primary solid brain tumours, including treatment administration in the Pear Bio system.

This trial is looking at whether a drug called olaparib improves the way radiotherapy and chemotherapy work. It is for people with a type of brain tumour called glioblastoma who are newly diagnosed and have recently had surgery.
Glioblastoma is one of the most common types of brain tumours in adults. Surgery and radiotherapy are the usual treatments. You might also have a chemotherapy drug called temozolomide. Olaparib is a type of biological therapy Open a glossary item called a PARP inhibitor. PARP is a protein that helps cells to repair. If PARP is blocked, cancer cells might not be able to repair themselves after chemotherapy or radiotherapy. In this trial, doctors hope that having olaparib might make these treatments work better. But they aren’t sure, so want to find out more. Glioblastoma tumour cells have areas of DNA Open a glossary item called MGMT. These areas can be low (methylated) or high (unmethylated). We know from recent research that people whose tumours have low MGMT seem to benefit from temozolomide, and those with high MGMT do not benefit from temozolomide.

As part of this trial, you won’t have temozolomide if you have unmethylated MGMT. But it might be possible to have higher and more frequent doses of olaparib with radiotherapy. The researchers will do a MGMT test before you start treatment. So far, a small number of people with glioblastoma have had olaparib and radiotherapy. And a small number have had olaparib and chemotherapy. But this is the first time people will have all 3 together. The aims of the trial are to find the highest safe dose of olaparib with chemotherapy and radiotherapy and to find out if having olaparib helps chemotherapy and radiotherapy work better. Please note, people who have high (unmethylated) MGMT can no longer join the trial as this group is closed to recruitment.  

Studies in Set Up

The Brain Tumour Data Accelerator (BTDA) is a multi-centre, rich, linked dataset combining information on adult patients with primary brain tumours. The aim of the project is to accelerate research into brain tumours, and thus improve care, treatments and outcomes for these patients.

The main data areas are: Patient demographics; Surgical data; Radiotherapy data; Chemotherapy data; Imaging data (CT and MRI brain, CT body); Clinical pathology & clinical genomics (I.e IDH, MGMT, 1p/19q); Pathology (specimen ID and specimen site) Survival; Disease progression. Further information including our study design, data flow, patient identification process, data governance and regulatory, ethical and legal issues are covered in detail in the BTDA protocol 0.5.

Analysis of Proton vs. Photon Radiotherapy in Oligodendroglioma and Assessment of Cognitive Health  

We want to improve treatment for people diagnosed with oligodendroglioma (ODG). ODG is a rare type of brain tumour, and many people continue to live for many years after diagnosis. The standard treatment for ODG involves surgery which will remove as much of the tumour as possible followed by radiotherapy (RT) and chemotherapy treatments. In the UK, standard radiotherapy treatment uses photon radiotherapy. This treatment is given as lots of small doses called fractions, usually on weekdays over 6 weeks. This is the best way to treat the tumour and minimise side effects in normal brain tissue. Sometimes, however, photon RT can cause long-term side effects in normal brain tissue. These side effects can develop many years after the treatment and may include memory problems or difficulties processing information. We call these sorts of problems ‘neurocognitive problems’. Proton Beam Therapy (PBT) is an alternative type of radiotherapy treatment. This treatment is also given on weekdays over 6 weeks. PBT can reduce the dose of RT delivered to normal brain tissue, including some of the parts of the brain that are involved in memory and processing information, and so we think PBT may cause fewer neurocognitive problems. This study will look at whether the lower doses to the normal brain tissue from PBT result in fewer long-term side-effects

Data will be obtained directly from participating trusts, who will be responsible for patient identification, linkage and pseudonymisation. There will be no person identifiable information in the dataset held by BTDA

Future Possible Trials

These trials are currently being designed and are on the horizon and will be assessed for site suitability within the next 12 months.

Recurrent GB Trial - Looking into recurrent glioblastoma. This is to find out in which patients surgery is helpful when glioblasoma comes back, and when this surgery should be performed. This trial is in the design phase. 

Liquid biopsy analysis for early diagnosis of brain tumours (INFORM study) IRAS 322779 - this innovative study is looking into using tear drops to diagnose and monitor brain tumours. At the moment the only way to diagnose and monitor a brain tumour is by using brain scans. A simple tear drop test could potentially be much faster and easier to do, even in at the GP.

Serum Biomarkers Trial - This is a corporate sponsored study looking into a new blood test which could diagnose and monitor brain cancer. This test would be faster, more cost effective and easier to do than a brain scan.  This study is in a design phase.

Whole Genome Sequencing

The Neuro-oncology service offers tissue storage and Whole Genome Sequencing. This enables the full genome of a tumour to be analysed and is a requirement for entry into some clinical trials. This is considered for all patients at our weekly Neuro-oncology Multidisciplinary Meeting- please ask your neuro-oncology team if you have any questions about this, or contact us through the contact us webpage.

Get involved

To find out further information, please contact your clinician at your next appointment or contact our Research and Innovation Department via the following link: https://www.bhrhospitals.nhs.uk/research-and-innovation or visit https://bepartofresearch.nihr.ac.uk/ where you can look for specific studies in a clinical area of interest to see what is running within the Department and at the Trust.