Neoplasms

Nervous System Diseases

All Conditions

Heart and Blood Diseases

Diseases and Abnormalities at or Before Birth

Blood and Lymph Conditions

Symptoms and General Pathology

Brain Neoplasms

Arteriovenous Malformations

Congenital Abnormalities

Vascular Malformations

Hemangioma, Cavernous

Hemangioma

Cardiovascular Abnormalities

Vascular Diseases

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Syndrome

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Hematologic Diseases

Image-guided resection of brain tumors and vascular malformations

Surgeon removes brain tumor or vascular malformation and assesses location of motor areas with functional navigation and intraoperative neuromonitoring

Functional navigation

Alexander Dmitriev, MD

The purpose of the study is to assess accuracy, advantages of functional neuronavigation and calculate safe distance from motor areas to brain tumors and vascular malformations in image-guided surgery.

Functional images (functional magnetic resonance imaging (fMRI), transcranial magnetic stimulation (TMS), tractography) loaded in neuronavigation are called functional navigation. It is usually combined with anatomical data and allows to display eloquent brain areas. Currently there are plenty of studies concerning possibilities of it's use. In our research we plan to confirm this data and to supplement them with calculating a safe distance from motor areas to various mass lesions in preoperative scans where neurological deficits is not likely to appear after surgery. In case of success this data can be a foundation for further researches specifying indications for use of intraoperative neuromonitoring and possibility of it's replacement with functional navigation in some cases.

The purpose of the study is to assess accuracy, advantages of functional neuronavigation and calculate safe distance from motor areas to brain tumors and vascular malformations in image-guided surgery. For each patient a surgeon intraoperatively will assess locations of motor cortex and corticospinal tract found with direct cortical and subcortical stimulation and capture them. After surgery he will compare this data with functional preoperative scans and virtual motor centers constructed based on tractography. Influence of various factors on precision of functional navigation will be studied and safe distance between motor brain areas and mass lesion borders will be calculated.

Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations

Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations: a Prospective, Single Arm Clinical Trial

Maximal distance from the most remote margin of cortical hand/leg motor area or corticospinal tract in the area of corona radiata in functional navigation to the nearest margin of this area/tract in direct cortical/subcortical stimulation

Maximal distance from the most remote margin of cortical hand/leg motor area, built according to tractography and loaded into navigation, to the nearest margin of this area in direct cortical stimulation

Maximal distance from the most remote margin of cortical hand/leg motor area in fMRI/TMS to the nearest margin of precentral gyrus

Which factors lead to disappearing, thinning and dislocation of cortical hand/leg motor areas and corticospinal tract in fMRI/TMS/tractography

Motor function is assessed in Medical Research Council scale

Minimal distance from the nearest margin of cortical hand/leg motor area or corticospinal tract to the nearest border of resection of tumor/vascular malformation

This outcome is only measured in patients with no deterioration of motor function after surgery. Safe resection distance = accuracy of functional navigation + distance to stop resection border

How long did it take to perform direct cortical and subcortical mapping

Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100

Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale

Which cerebral complications arose after surgery

Sklifosovsky Institute of Emergency Care

Principal Investigator

Cerebral Hemorrhage

Hematoma

Hemorrhage

Intracranial Hemorrhages

Cerebrovascular Disorders

Ultrasound-guided resection of brain tumors, vascular malformations and hematomas

Surgeon detects brain mass lesion and assesses extent of it's resection with sonography

Sonography

Objective of the study is to determine possibilities of intraoperative sonography in detecting of various brain mass lesions, assessing extent of their resection and define indications to use ultrasound-guided needle or ultrasound wire-guided port.

Intraoperative sonography is usially used in neurooncology to detect brain tumors and exclude their remnants. A few studies describe it's usage while removing hematomas or vascular malformations. Ultrasound is the only method allowing to observe brain tissue in real time. It is chip and doesn't violate surgical workflow. Main disadvantages of sonography are lengthy learning curve and poorer image quality compared to magnetic resonance imaging. Novel acoustic coupling fluid, contrast-enhanced ultrasound and elastography expanded it's effectiveness. Meanwhile problems of locating of isoechogenic lesions with poor margins and elimination of artefacts are steel actual.

Objective of the study is to determine possibilities of intraoperative sonography in detecting of various brain mass lesions, assessing extent of their resection and define indications to use ultrasound-guided needle or ultrasound wire-guided port.

A surgeon will intraoperatively locate mass lesion and assess extent of it's resection with sonography. Ultrasound scanning will be performed through the same surgical approach or at a distance through enlarged craniotomy, periodically or permanently. To facilitate approach to subcortical and deep small mass lesions ultrasound-guided needle or ultrasound wire-guided port will be used.

Sonography-guided Resection of Brain Mass Lesions

Sonography-guided Resection of Brain Mass Lesions: a Prospective, Single Arm Clinical Trial

Assessment of target visibility, echogenicity, homogeneity and border demarcation in sonography and their comparison to preoperative computed tomography and magnetic resonance imaging

Sensitivity = true detection of mass lesion / (true detection of mass lesion + inability to detect mass lesion) x 100

Sensitivity = true detection of residual mass lesion / (true detection of residual mass lesion + inability to detect residual mass lesion) x 100

Specificity = true absence of residual mass lesion / (true absence of residual mass lesion + false detection of residual mass lesion) x 100

Positive predictive value = true detection of residual mass lesion / (true detection of residual mass lesion + false detection of residual mass lesion) x 100

Negative predictive value = true absence of residual mass lesion / (true absence of residual mass lesion + inability to detect residual mass lesion) x 100

Accuracy = (true detection of residual mass lesion + true absence of residual mass lesion) / (true detection of residual mass lesion + true absence of residual mass lesion + false detection of residual mass lesion + inability to detect residual mass lesion) x 100

How long did in take to remove mass lesion from starting of it's dissection till final evacuation

Possibility of ultrasound differentiation between artefacts and residual lesion

Only for subcortical or deep-seated mass lesions. How long did in take to reach margin of mass lesion after dural incision using ultrasound-guided needle or ultrasound wire-guided port

Rare Diseases

Disease Susceptibility

Hemangioma, Cavernous, Central Nervous System

Central Nervous System Vascular Malformations

Nervous System Malformations

Familial Cerebral Cavernous Malformation

The adjudicated definition of CASH (Cavernous Angiomas with Symptomatic Hemorrhage) requires diagnostic evidence of new lesional bleeding or hemorrhagic growth, in association with directly attributable symptoms.

Issam A Awad, MD

Daniel Hanley, MD

Kelly Flemming, MD

Helen Kim, MPH, PhD

Brain Cavernous Angiomas with Symptomatic Hemorrhage (CASH) are rare, but they exact a heavy burden of neurologic disability from recurrent bleeding, for which there is no proven therapy. This trial readiness project aims to address current critical obstacles in identifying cases at multiple sites, characterizing their relevant features, and measuring their outcome. The timing cannot be more opportune, with therapeutic targets already identified, exceptional collaboration among researchers and with the patient community, and several drugs ready to benefit from a track to clinical testing in the next five years.

The Trial Readiness grant mechanism, funded by NINDS, proposes to address knowledge gaps and establish a research network as infrastructure for future research. This project includes an observational cohort study of 181 patients with an operational goal of demonstrating the feasibility of screening, enrollment rates, baseline disease categorization and follow-up of CASH using common data elements at multiple sites, and to assess the following endpoints for 123 participants enrolled at centers prespecified to do prospective follow-up: (1) the rates of recurrent hemorrhage; (2) the reliability of imaging biomarkers including quantitative susceptibility mapping and permeability measures which have been shown to correlate with lesion activity, and (3) change in functional status during prospective follow-up.

CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness

Study Protocol has been published in Neurosurgery

Number of new bleeds reported during the two year follow-up period in the cohort with CASH. We will assess the change in the number of bleeds from baseline to year 1, baseline to year 2, and year 1 to year 2 year follow-up.

Change in QSM value will be assessed from baseline to year 1 and year 1 to year 2 follow-up MRIs.

Change in DCEQP value from the MRIs will be assessed from baseline to year 1 and year 1 to year 2 of follow-up

Change in the proportion of patients with mRS score 0 to will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

The mRS is a simple global measure of functional disability. Scores range from 0 (no symptoms) to 6 (death). An mRS score of 0 to 1 is considered a minimal clinical disability, and 0 to 2 is independent.

Change in median NIHSS value will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

NIHSS values range from 0 to 42, with stroke severity categorized as mild (0 to 4), moderate (5 to 14), severe (15 to 24), and very severe (≥25). 4-point decline in ischemic stroke clinical trials typically measures functional decline.

Change in the median score of EQ-VAS will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Change in proportion of patients with no problems, mild, or severe problems in the "Mobility" domain of EQ-5D-3 L will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems.

Change in proportion of patients with no problems, mild, or severe problems in the "Self-care" domain of EQ-5D-3 L will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems.

Change in proportion of patients with no problems, mild, or severe problems in the "Usual activities" domain of EQ-5D-3 L will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems.

Change in proportion of patients with no problems, mild, or severe problems in the "Pain / Discomfort" domain of EQ-5D-3 L will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems.

Change in proportion of patients with no problems, mild, or severe problems in the "Anxiety / Depression" domain of EQ-5D-3 L will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems.

Change in the median T-score for "Anxiety" domain of PROMIS-29 will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points).

Change in the median T-score for "Depression" domain of PROMIS-29 will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points).

Change in the median T-score for "Fatigue" domain of PROMIS-29 will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points).

Change in the median T-score for "Pain" domain of PROMIS-29 will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points).

Change in the median T-score for "Sleep Disturbance" domain of PROMIS-29 will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points).

Change in the median T-score for "Social" domain of PROMIS-29 will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, and ability to participate in social roles and activities, and physical function).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points).

Change in the median T-score for "Physical Function" domain of PROMIS-29 will be assessed from baseline to year 1 and year 1 to year 2 follow-up periods.

PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, and ability to participate in social roles and activities, and physical function).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points).

Mayo Clinic

Johns Hopkins University

University of California, San Francisco

National Institute of Neurological Disorders and Stroke (NINDS)

University of Utah

University of New Mexico

Barrow Neurological Institute

University of Chicago

Removing different brain lesions using neuronavigation

Surgeon removes brain lesions and assesses brain shift with neuronavigation

Navigation-guided surgery

The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.

Brain shift is the main natural cause of major navigation imprecision. Despite numerous attempts no trials showed a possibility to calculate and predict it's value although some patterns were found. Some modern navigational features allow to partially resolve this problem. Manual shift correction allows to displace brain structures but can only be used if brain shift is linear. Intraoperative computed tomography (CT) and magnetic resonance imaging (MRI) allow to update navigational data but violate surgical workflow and cannot display brain tissue in real time. Intraoperative sonography has poorer quality, limited observe volume and lengthy learning curve.

The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.

For each patient a surgeon intraoperatively will assess location of brain surface, various intracranial structures and lesion margins during surgery. Postoperatively these data will be compared to lesion's characteristics, patient's state and intraoperative features.

Intraoperative Brain Shift Calculation Study

Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial

Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location

Assesses patients' possibilities to self-service

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations	NCT05484219	Tumor, Brain Arteriovenous M... Cavernoma	Functional navi...	18 Years - 79 Years	Sklifosovsky Institute of Emergency Care
Sonography-guided Resection of Brain Mass Lesions	NCT05484245	Tumor, Brain Arteriovenous M... Cavernoma Intracerebral H...	Sonography	18 Years - 100 Years	Sklifosovsky Institute of Emergency Care
Sonography-guided Resection of Brain Mass Lesions	NCT05484245	Tumor, Brain Arteriovenous M... Cavernoma Intracerebral H...	Sonography	18 Years - 100 Years	Sklifosovsky Institute of Emergency Care
CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness	NCT03652181	CCM Cavernoma Cerebral Cavern... Cerebral Cavern... Cerebral Cavern... Cerebral Cavern... Cavernous Angio...		18 Years -	University of Chicago
CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness	NCT03652181	CCM Cavernoma Cerebral Cavern... Cerebral Cavern... Cerebral Cavern... Cerebral Cavern... Cavernous Angio...		18 Years -	University of Chicago
Intraoperative Brain Shift Calculation Study	NCT05477680	Tumor, Brain Cavernoma Arteriovenous M... Intracerebral H...	Navigation-guid...	18 Years - 100 Years	Sklifosovsky Institute of Emergency Care

Spots Global Cancer Trial Database for cavernoma

Every month we try and update this database with for cavernoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cavernoma

Every month we try and update this database with for cavernoma cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cavernoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.