Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Blood and Lymph Conditions

Mouth and Tooth Diseases

Rare Diseases

Uterine Cervical Neoplasms

Carcinoma

Cholangiocarcinoma

Breast Neoplasms

Pancreatic Neoplasms

Melanoma

Prostatic Neoplasms

Stomach Neoplasms

Glioblastoma

Brain Neoplasms

Astrocytoma

Anorexia

Vomiting

Head and Neck Neoplasms

Sarcoma

Carcinoma, Renal Cell

Neoplasm Metastasis

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Headache

Liver Neoplasms

Seizures

Sleepiness

Mesothelioma

Mesothelioma, Malignant

Mitral Valve Insufficiency

Kidney Neoplasms

Esophageal Neoplasms

Thymoma

Thymus Neoplasms

Tongue Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplastic Processes

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Adenoma

Neoplasms, Mesothelial

Thoracic Neoplasms

Glioma

Neoplasms, Neuroepithelial

Esophageal Diseases

Lymphatic Diseases

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Tongue Diseases

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

Bile Duct Cancer

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Malignant Mesothelioma

Tongue Cancer

Neuroepithelioma

Oral Cancer

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Temozolomide

Intravenous administration of QBS10072S once every 4 weeks starting at 3mg/m2 and increasing dose levels in subsequent cohorts.

QBS10072S targets cancers with high LAT1 expression.

QBS10072S

This is a multi-center, open-label, dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of QBS10072S in patients with advanced or metastatic cancers with high LAT1 expression. The MTD of QBS10072S will be confirmed in patients with relapsed or refractory grade 4 astrocytoma.

The dose escalation scheme for this trial employs an mTPI-2 design.

Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S

A Phase 1, Open Label, Multi-Center, Single and Multiple Dose, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S in Previously Treated Patients With Advanced or Metastatic Cancers With High LAT1 Signatures, and in Patients With Relapsed or Refractory Grade 4 Astrocytoma

MTD will be determined by presence of AEs as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.

Safety and tolerability will be determined by adverse events as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.

Determine the maximum plasma concentration of QBS10072S.

Determine the plasma concentration of QBS10072S over time.

Determine the half life of QBS10072S in plasma; the half-life of a drug is the time taken for the plasma concentration of a drug to reduce to half its original value.

Determine the time it takes to achieve maximum concentration of QBS10072S in plasma.

Novotech (Australia) Pty Limited

Quadriga Biosciences, Inc.

Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher

Medical Monitor

This study will evaluate the test-retest repeatability of lactate and other metabolites measured by single voxel magnetic resonance spectroscopy (MRS) and multi-voxel magnetic resonance spectroscopic imaging experiments (MRSI) in tumor tissue in patients radiographically diagnosed with glioma.

These measurements will test whether the concentration of lactate in tumor will be higher than the concentration of lactate in normal tissue of the same patient.

Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism (MK-0000-145)

Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism

Merck Sharp & Dohme LLC

Immune System Diseases

Encephalitis

Anti-N-Methyl-D-Aspartate Receptor Encephalitis

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Hashimoto Disease

Neuroinflammatory Diseases

Thyroiditis

Thyroiditis, Autoimmune

Thyroid Diseases

Endocrine System Diseases

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Neurodegenerative Diseases

Autoimmune Encephalitis

Hashimoto Encephalopathy

Lymphomatous Thyroiditis

Antibodies

Autoantibodies

Immunoglobulins

Children and young people (ages 8-24 years) with a diagnosis of NMDAR-antibody encephalitis.

Children and young people (ages 8-24 years) with a diagnosis of autoantibody-negative but probable autoimmune encephalitis or definite autoimmune limbic encephalitis.

Healthy children and young people (ages 8-24 years).

Not applicable - non-interventional study

Michael R Eyre, MBBS MRes

David W Carmichael, PhD MSci

Ming J Lim, MBBS PhD

Autoimmune encephalitis is brain inflammation caused by the immune system mistakenly reacting against proteins in the brain. The commonest form is called NMDAR-antibody encephalitis (N-methyl-D-aspartate receptor antibody encephalitis), a rare condition which mainly affects children and young people and causes difficulties in memory, thinking and mental health which can have significant long-term impacts on education, employment and quality of life.

In this project we will use advanced magnetic resonance imaging (MRI) to measure changes in the structure, function and chemistry of the brains of children and young people who are in early recovery from NMDAR-antibody encephalitis and other forms of immune-mediated encephalitis. We will investigate if MRI measurements in patients differ from those in healthy people, and if they can help predict patient outcome one year later, assessed by tests of memory, thinking, mental health and functioning in daily life.

This study aims to develop non-invasive, in vivo measures of neurobiological dysfunction derived from the overarching hypothesis that dysfunction of inhibitory interneurons alters the cerebral concentrations of gamma-aminobutyric acid (GABA) and glutamate (Glu) and underlies T2 changes and deficient connectivity in functional networks in early recovery from NMDAR-antibody encephalitis. Our ambition is to identify the best potential prognostic biomarkers from these neurometabolite measurements and structural and functional MRI.

Our primary objective is to test the following specific hypotheses in children and young people with NMDAR-antibody encephalitis:

* Hypothesis 1: GABA is decreased, and Glu increased, on MR spectroscopy of the medial temporal lobe and medial prefrontal cortex in NMDAR-antibody encephalitis.
* Hypothesis 2: Local GABA and Glu are correlated with (i) resting-state functional MRI (fMRI) based functional connectivity and (ii) parameter map-based microstructural changes. Specifically, we hypothesise that (i) GABA is positively correlated and Glu inversely correlated with functional connectivity, assessed by whole-brain mapping of the default mode network and seed-based analysis of hippocampal-frontal connectivity; and (ii) Glu is positively correlated and GABA inversely correlated with median T2 values within the hippocampus.
* Hypothesis 3: Local neurometabolites, network measures and microstructural changes predict cognitive, psychiatric and functional outcome at one year. Specifically, we hypothesise that medial temporal Glu, GABA and hippocampal T2 predict memory performance, and prefrontal Glu and GABA predict attention, executive function and fluid intelligence.

Developing Advanced Neuroimaging for Clinical Evaluation of Autoimmune Encephalitis

Consent will be requested from participants to share imaging data and summary clinical and demographic data. Where participants consent, imaging data will be de-identified, removing facial features from the magnetic resonance images and all identifying information will be removed from the image header (the part of the file that describes how the image data was acquired). The resulting data will be shared together with anonymised clinical data at the request of other researchers.

Measured with MR spectroscopy - stimulated echo acquisition mode (STEAM) sequence

Quantitative MRI parameter maps including measurement of median T2 values in the hippocampus

Whole-brain mapping of the default mode network and seed-based analysis of hippocampal-frontal connectivity

Cognitive test (higher score indicating better outcome)

Questionnaire-based psychiatric symptom score (lower score indicating better outcome)

Questionnaire-based functional outcome score (higher score indicating better outcome)

Questionnaire-based functional outcome score (lower score indicating better outcome)

Guy's and St Thomas' NHS Foundation Trust

Action Medical Research

King's College London

Recurrence

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

All patients will receive Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally receive bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until progression.

One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS

Patients will receive bevacizumab (10 mg/kg) one day before and then at day 14 followed by10 mg/kg/day every 14 days until progression.

Magnetic Resonance Spectroscopy (MRS)

The 'border zone' of the tumor will be targeted by SRS in a single session.

Border Zone Stereotactic Radiosurgery (BZ-SRS)

Ajay Niranjan, MD

This is a phase II study on the usage of stereotactic Gamma Knife radiosurgery as a boost to the tumor bed border zone in conjunction with the usage of bevacizumab.

Glioblastoma Multiforme (GBM) is the most common primary brain tumor in adults. Unfortunately, despite aggressive surgery, radiation therapy (RT) and chemotherapy, the prognosis for this disease is poor. It is our hypothesis that GBM is a "local" disease wherein treatment failure is due to failure to eradicate tumor cells in the pathways along which the tumor eventually spreads (the "border zone").

The investigators hypothesize that treatment volume escalation will be successful at improving overall survival in patients with GBM when appropriate targeting and precision dose delivery is performed in a single treatment session. The 'border zone' of the tumor will be targeted for SRS (defined as a combination of the MRI volume of gadolinium enhancement plus up to 2 cm of the surrounding T2 volume). This represents the volume of tumor infiltrated white matter and is the route of GBM spread. Bevacizumab, a monoclonal antibody to vascular endothelial growth factor (VEGF), has been used with safety and clinical success with concomitant chemotherapy in solid tumors, including GBM.

The investigators further hypothesize that a combined approach of SRS with this VEGF inhibitor will be an effective strategy for GBM because bevacizumab will maximize the effects of radiation in the treated volume and potentially reduce radiation toxicity in the adjacent brain.

Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Glioblastoma Multiforme

Multicenter Phase II Study of Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Multiforme

The number of months that a patient remains alive from the day first gamma knife surgery until the date of death or end of data collection for survival.

The proportion of patients who did not experience disease progression per RANO as of 6 months from the date of radiosurgery. RANO (Response Assessment in Neuro-Oncology) Response Criteria for Progression using imaging features: 25% or more increase in enhancing lesions despite stable or increasing steroid dose increase (significant) in non-enhancing FLAIR/T2W lesions, not attributable to other non-tumor causes any new lesions clinical features clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease). Proportion of patients for PFS = number of patients without disease at 6 months post radiosurgery / total number of patients.

The proportion of patients who remained alive as of 6 months from the date of radiosurgery. Proportion of patients for OS = number of patients alive at 6 months post radiosurgery / total number of patients.

The number of patients experiencing a CNS toxicity type occurring within 3 months of gamma knife surgery, as measured by RTOG/EORTC Acute Radiation Morbidity Scoring and the NCI CTCAE v4.0 for late toxicity.

Proportion of patients with a best response of CR, PR, SD, PD: number of patients with CR, PR, SD or PD / total number of patients evaluable for response to treatment of border zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab.

Improvement of border zone target selection and detection of therapeutic response of the derived treatment volumes between MRI and MRI+MRS (Magnetic Resonance Spectroscopy).

This is presented as the number of patients for whom the derived treatment was changed as a result of the utilization of MRS.

The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. Score range from 0 to 100; the lower the Karnofsky score, the worse the survival for most serious illnesses. A score of 100 would indicate 'Normal no complaints; no evidence of disease.' A score of 50 indicates 'Requires considerable assistance and frequent medical care.' A score of 0-10 would indicate 'Moribund; fatal processes progressing rapidly' and 'Death'.

The Barthel Index consists items assessing the ability to achieve certain activities without assistance. It evaluates the ability of feeding, moving from wheelchair to bed and returning, doing personal toilet, getting on and off toilet,bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. Scoring ranged from 0 (completely dependent) to 20 (completely independent) for this assessment. A maximal score of 20 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.

An assessment comprised of 20 statements for which the participant is asked to indicate how often they have felt a certain way during the past week. SCORING: zero for answers of Rarely or none of the time (less than 1 day), 1 for answers of Some or a little of the time (1-2 days), 2 for answers of Occasionally or a moderate amount of time (3-4 days) the third column, 3 for answers of Most or all of the time (5-7 days). The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more depression symptomatology.

The FACT-G is a patient rated, 27-item compilation of general questions divided into 4 primary Quality of Life (QOL) sub-scales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). This tool represents the generic core questionnaire that are utilized in combination with cancer site-specific questionnaires, (FBrain, in this study) Overall score and four subscale scores with ranges and distributions that are sample-specific can be calculated.FACT-G is scored by summing the individual scale scores; higher scores indicate better quality of life. FACT-G uses 5-point rating scale ranging from (0) = Not at all; (1) = A little bit; (2) = Somewhat; (3) = Quite a bit; to (4) = Very much.The FACT-G total score is the sum of the four subscale scores (if least 80% completed) and has a possible range of 0-108 points.

The FACT-BrSI subscale, brain tumor specific version (2007), is a 15-item, patient completed, questionnaire.This brain subscale is used along with the core (general) questionnaire (FACT-G) that includes 27 items. Patients rate all items using a five-point Likert scale ranging from 0 "not at all" to 4 "very much." Overall, higher ratings suggest higher quality of life (QOL). The FACT BrSI has a range of 0-60, where a higher score indicates less symptomatology.

Genentech, Inc.

Ajay Niranjan

Professor

All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.

BZ-SRS With Bevacizumab

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S	NCT04430842	Astrocytoma Brain Cancer Brain Metastase... Bladder Cancer Breast Cancer Cervical Cancer Cholangiocarcin... Colorectal Canc... Esophagus Cance... Gastric Cancer Head and Neck C... Kidney Cancer Liver Cancer Lung Cancer Melanoma Ovarian Cancer Pancreatic Canc... Pleural Mesothe... Prostate Cancer Sarcoma Tongue Cancer Thymic Carcinom... Urinary Tract C...	QBS10072S	18 Years -	Quadriga Biosciences, Inc.
Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism (MK-0000-145)	NCT01138813	Glioma		18 Years - 70 Years	Merck Sharp & Dohme LLC
Developing Advanced Neuroimaging for Clinical Evaluation of Autoimmune Encephalitis	NCT05280600	Anti-N-Methyl-D... Autoimmune Ence...	Not applicable ...	8 Years - 24 Years	King's College London
Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Glioblastoma Multiforme	NCT02120287	Glioblastoma Mu... Glioblastoma - ...	Bevacizumab Magnetic Resona... Border Zone Ste...	18 Years -	University of Pittsburgh
Non-Invasive Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy Techniques (MRS) for Assessing Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer	NCT00490503	Breast Cancer	Magnetic Resona... Magnetic Resona...	18 Years -	M.D. Anderson Cancer Center
Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors	NCT00581906	Head and Neck C...	DCE-MRI, DW-MRI...	18 Years -	Memorial Sloan Kettering Cancer Center
Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Glioblastoma Multiforme	NCT02120287	Glioblastoma Mu... Glioblastoma - ...	Bevacizumab Magnetic Resona... Border Zone Ste...	18 Years -	University of Pittsburgh

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