Clinical Research Directory

A Phase I, Single-arm, Open-label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of CHT101 Cell Infusion in Adult Subjects With Recurrent or Progressive Malignant Primary Brain Tumors（CROWN）

Recurrent or progressive primary malignant brain tumors are among the malignancies with a poor prognosis. They refer to primary brain tumors that either recur after standard treatment or show disease progression during the course of standard therapy. This group includes a variety of histological types, most commonly glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, and primary central nervous system lymphoma.

Clinical, patHOlogical and Imaging Project of nEuro-oncology (HOPE)

Primary central nervous system (CNS) tumors, the vast majority (\>90%) occurring in the brain and the remainder occurring in the meninges, spinal cord, and cranial nerves, showing an annual incidence of about 6-8 people per 100,000 population but its effects on health-care systems is out of proportion with incidence due to the substantial high rates of morbidity and mortality. Among which, glioma disease is the most common primary malignant CNS tumor, while the glioblastoma that showed the highest degree of malignancy and the worst prognosis accounts for 70-75%. The construction goal of this project is to construct a multivariate retrospective CNS tumor database (over 50,000 cases, including 10,000 glioma) integrating clinical information, preoperative magnetic resonance imaging examination and molecular pathological results, and a prospective glioma database (3,000 cases) integrating advanced magnetic resonance sequences and postoperative follow-up. It aims to form a standardized database integrating magnetic resonance imaging, pathological results, and clinical-prognostic information. Based on the construction of the above standardized database, the specifications for the acquisition of cranial magnetic resonance images, the image segmentation, tumor classification and labeling process, and the expert consensus on database construction and use management of CNS tumors were established. We aim to form a multimodal, large-capacity, high-quality, and rich medical imaging database that conforms to the characteristics of Chinese groups and clinical diagnosis and treatment norms. On this basis, the data are dynamically updated, in-depth mining, and the classification and grading standards of CNS tumor diseases, prognosis judgment criteria and treatment efficacy evaluation system are formulated, and providing comprehensive resources of retrospective data and prospective cohorts for large-scale reasearches, such as classification or treatment intervention predictions.

MRinRT: Swansea University and SWWCC Collaboration Study.

The aim of this study is to learn whether using MRI (magnetic resonance imaging) scans to plan radiotherapy is better than using CT (computed tomography) scans alone. The main questions it aims to answer is: * Can MRI scan images be adjusted to make the tumour and normal tissues easier to see? * Does adding MRI to a radiotherapy planning CT make the radiotherapy plan more precise? * Can MRI be used to adjust a radiotherapy plan during a course of treatment to make it more precise, and might that reduce the side effects? * Are there particular MRI scans that can predict how a tumour will respond to radiotherapy or how likely the patient is to have side effects? This study will assess current MRI scanning procedures and ensure these are adjusted to best suit radiotherapy planning. It will also provide pilot data evaluating: 1. MRI-adapted radiotherapy Usually, radiotherapy plans are based on a pre-treatment planning CT scan. Unless an issue is detected the patient would complete their whole course of radiotherapy on this plan. This does not account for changes in position/size/shape of the tumour that occur over the whole treatment course. Clinicians therefore increase the size of the tumour/target to account for these uncertainties, which can increase side effects. This study will assess the potential to reduce side effects from radiotherapy by using repeat MRI scans and replanning during the treatment course (MRI-adaptive radiotherapy). 2. Imaging biomarkers MRI sequences can be used to predict response to radiotherapy or chance of developing side effects. This study will identify potential MRI sequences that may be used as imaging biomarkers, to guide the development of future clinical trials. The study will be undertaken at SBUHB, lasting 4 years, and involving ≤15 healthy volunteers and ≤150 patients.

Pharmacoscopy for Patients With Refractory Primary Brain Tumors

Advanced technology of ex vivo drug profiling referred to as pharmacoscopy may allow to identify novel drugs for the treatment of glioblastoma and other refractory brain tumors at an individual patient level. This personalized therapeutic approach was developed and validated in pre-clinical glioma models. With the current research proposal, we seek to establish feasibility for a clinical interventional trial for patients with refractory primary brain tumors that is based on pharmacoscopy-guided selection of treatment. The study is supported by an unrestricted grant from Anti Cancer Fund.

Combined Gamma Knife/Linac Radiosurgery for Large Brain Tumors / Metastases

When cancer spreads to the brain, doctors often use a precise type of radiation therapy called stereotactic radiosurgery (SRS) to treat these tumors. This treatment can effectively control brain tumors while helping protect healthy brain tissue. However, when brain tumors or the areas where tumors were surgically removed are larger, treatment outcomes in terms of side effects and tumour control can become worse. Specifically, standard SRS on larger areas can have lower tumour control and higher risk of side effects, particularly a condition called radiation necrosis, which can cause swelling and damage in nearby healthy brain tissue. Currently at Sunnybrook, large brain tumors are typically treated with SRS spread over 5 daily treatments using a machine called a linear accelerator. While this approach works well for many patients, it may be possible to improve results by combining two different types of radiation therapy machines - the linear accelerator and another specialized machine called the Gamma Knife. In this study, the investigators want to test a new treatment approach where patients first receive 4 daily treatments using the linear accelerator, followed by a 1-2 week break, and then a final treatment using the Gamma Knife. The break between treatments allows the study doctors to take new scans and precisely target any remaining tumor, which may shrink during the break, thereby potentially reducing the amount of healthy brain tissue exposed to radiation. The Gamma Knife is also particularly good at delivering very precise radiation while sparing nearby healthy tissue. Lastly, there may be unique biological mechanisms between the two technologies that could be taken advantage of, by combining the technologies in the participant's treatment plan, to improve cancer control. The investigators believe this combined approach might help achieve better tumor control while reducing the risk of side effects compared to using just the linear accelerator. This study will help the investigators understand if this new treatment strategy is safe and effective for patients with large brain tumors or surgical cavities, and whether it leads to better outcomes than the current treatment approach.

A Vision-Language Foundation Model for Brain Disease Diagnosis From Multimodal Data

The goal of this observational study is to develop an innovative, comprehensive, and explainable AI vision-language foundation model (VLM) to advance the diagnosis and interpretation of brain diseases using multi-modal data. We will include patient demographics, medical imaging data (such as MRI, CT, and PET scans), histopathological data, genomic data when available, and other necessary laboratory examinations and tests to establish a screening and diagnostic model for brain diseases.

3D Decision Support Tool for Brain Tumour Surgery Development and Validation: Observational Study

This observational study (STRATUM-OS) aims to collect the necessary data from a cohort of patients with planned surgery for suspected intra-axial malignant brain tumours (both primary and secondary) following the standard surgical procedure established in current clinical protocols. These data will serve two primary purposes: i) To gather multimodal data (pre, intra and postoperative) essential for the development and technical validation of a 3D decision support tool for brain surgery guidance and diagnostics integrating augmented reality and multimodal data processing powered by artificial intelligence algorithms (called STRATUM tool); ii) To collect outcome measures that will facilitate a subsequent comparative study (a non-randomized controlled clinical trial, called STRATUM-NRCCT) assessing the standard procedure alone versus the standard procedure augmented with the STRATUM tool. Patients from STRATUM-OS will act as a historical control group in the subsequent historically controlled clinical trial (STRATUM-NRCCT), which will be performed once STRATUM-OS has been completed. In STRATUM-OS patients will receive standard care as per established clinical protocols, with no modification to their treatment. However, patients will be asked to grant access to their clinical information, complete questionnaires, and provide relevant pre, intra and postoperative information related to the surgical intervention. Data will be gathered from multiple sources, such as the Electronic Health Records (EHR), patient completed questionnaires, interviews, and reports from healthcare professionals involved in the surgical procedure. Additionally, intraoperative data will be collected from the different devices in the operating room.

Project MILANO: Connections Between Patients With Brain Tumors and Their Pets: an Analysis of Concerns and Needs

Context and problem In France, 61% of households own a pet, highlighting the significant role pets play in the daily lives. Patients diagnosed with brain tumors face specific challenges that may affect their ability to care their pets, including: * Progressive neurological deficits (cognitive and/or motor), limiting their autonomy, * A life-threatening prognosis. In this context, the well-being of pets when their owner's health deteriorates becomes a critical concern. Indeed: * Social isolation and the progressive loss of physical and cognitive abilities complicate pet care, particularly during prolonged hospitalizations or in the event of death, * The lack of appropriate facilities and care solutions causes stress for pets, who are often unprepared for such transitions, and adds to the emotional burden on patients. Why focus on patients with brain tumors? * These patients have specific needs due to the rapid progression of their condition, * A local study showed that 12% of patients with gliomas live alone, a significantly higher rate than in other cancer types. Patients who live alone are particularly exposed to issues related to their pet's future, * Given the high morbidity and mortality associated with brain tumors, proactive planning for pet care is particularly urgent.

Study of MT027 in Patients with Brain, Meninges, and Spinal Cord Metastatic Solid Tumors

MT027 is an off-the-shelf, allogeneic chimeric antigen receptor T cell (UCAR-T) injection prepared from healthy donor T cells targeting B7-H3. It is a next-generation, ready-to-use CAR-T product that can be used immediately and promptly for patients to solve the problem of unmet medical needs for a large number of patients who have a demand for CAR-T therapy but cannot receive it due to the common reasons of long production cycle, insufficient production capacity, and incompatibility of patients' T cells with the production conditions. In addition, the expected medical cost of allogeneic CAR-T cells is significantly lower, which can greatly alleviate the economic burden on patients. MT027 is prepared by expressing a chimeric antigen receptor (CAR) targeting B7H3 on gene-edited T cells through gene modification technology. MT027 products targeting the B7H3 target developed by Moxing Biotech avoid the potential graft-versus-host disease (GvHD) and host anti-graft reaction (HvGR) caused by the interaction between exogenous T cells and the patient's immune system, and have shown good safety and efficacy in recurrent high-grade glioma in the initial phase.