AMRI scan performed within 2 weeks before standard of care brain surgery.

During the surgery, neurosurgeon(s) use the information collected from the AMRI to decide what area of the brain tumor will be biopsied.

AMRI scan performed within 2 weeks before standard of care brain biopsy and tumor removal surgery.

AMRI scan should take less than 1 hour to complete

Advanced Magnetic Resonance Imaging Scan

During the surgery, the neurosurgeon(s) uses the information collected from the AMRI to decide what area of the brain tumor will be biopsied.

Biopsies from up to 5 locations taken before the tumor is surgically removed.

Standard of Care Brain Biopsy and Tumor Removal

Dawid Schellingerhout, MD

The goal of this clinical research study is to learn if using advanced magnetic resonance imaging (AMRI) will improve the targeting of brain tumor needle biopsies compared to the standard targeting techniques. Researchers also want to learn how the results of the images and biopsies compare to each other to try to improve the way researchers and radiologists use AMRI images.

This is an investigational study. The perfusion scan is not FDA approved or commercially available. It is currently only being used in research.

There will be no cost to you for the advanced MRI, additional anesthesia, special pathology stains, and/or gene testing for this study.

Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.

Participant is being asked to take part in this study because participant has a lesion in participant's brain which is suspected or proven to be a tumor and participant has been scheduled for surgery to remove it.

Some parts of brain tumors are more aggressive than other parts. A needle biopsy only gets a small part of the brain tumor cells. Doctors (neurosurgeons) want to get a biopsy sample from the most aggressive part of the tumor. Researchers think that AMRI techniques may help to better target the most aggressive part of the tumor for the needle biopsy.

AMRI Scan:

In addition to the images that will be taken as part of participant's standard of care surgery preparation, participant will have an AMRI scan performed. The AMRI has several parts. There are 2 perfusion scans that use a contrast dye to look at small blood vessels. There is a spectroscopy scan to looks at the chemical make-up of the tumor. There is also a diffusion scan to look at how water moves in the tumor and can see the white matter that connects both sides of brain parts. The AMRI scans are performed in the same way as normal MRI scans and in the same scanner. They can be noisy, but do not feel any different than standard MRI exams.

In most cases, the AMRI should take less than 1 hour to complete and will be performed within 2 weeks before participant's standard of care surgery.

Surgery During the surgery, the neurosurgeon(s) will use the information collected from the AMRI to decide what area of the brain tumor will be biopsied. The biopsies are only from areas that would normally be cut out during surgery and will not change the way the surgery is done even if participant chooses not to take part in this study. Biopsies (from up to 5 locations, each smaller than participant's thumbnail) will be taken before the tumor is surgically removed. The tumor tissue samples from the biopsies will be tested to learn more about the tumor and optionally the DNA inside(the genetic material of cells - this procedure is described in the optional procedures section below).

After the surgery is over, participant will continue to have participant's standard of care follow-up appointments in the neurosurgery clinic.

Length of Study After the biopsy is complete, your active participation on this study will be over. Participant's medical records will continue to be reviewed for up to an additional 5 years.

Follow-Up Medical Record Review:

After participant's active participation on this study is over, participant's medical record will be reviewed to learn how participant is doing, what other treatments participant may have had and how they worked, if participant had any new brain problems or if the tumor came back. Researchers will review and record information from participant's medical records for up to 5 years after participant's active participation on this study is over.

Radiologic Pathologic Correlation of Advanced MR Imaging to Guide the Biopsy of Cerebral Malignancies

Researchers wish to determine if the accuracy of the pathological grade observed at the biopsy sites identified by advanced imaging is higher than the grades observed at the biopsy sites identified by conventional imaging.

The quantitative pathology markers compared between the conventional and advanced target specimens.

M.D. Anderson Cancer Center

Nervous System Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Heart and Blood Diseases

Wounds and Injuries

Musculoskeletal Diseases

Mouth and Tooth Diseases

Rare Diseases

Neuralgia

Neoplasm Metastasis

Recurrence

Aneurysm

Fractures, Bone

Brain Diseases

Hydrocephalus

Spinal Diseases

Constriction, Pathologic

Brain Neoplasms

Trigeminal Neuralgia

Spinal Stenosis

Cysts

Spinal Fractures

Spinal Cord Neoplasms

Spinal Curvatures

Central Nervous System Neoplasms

Nervous System Neoplasms

Central Nervous System Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Pain

Neurologic Manifestations

Bone Diseases

Trigeminal Nerve Diseases

Facies

Facial Neuralgia

Facial Nerve Diseases

Mouth Diseases

Stomatognathic Diseases

Cranial Nerve Diseases

Spinal Injuries

Back Injuries

Spinal Cord Diseases

The primary intervention of the Transitional Care Programme (TCP) will be additional patient education, framing of expectations for the hospital course and length of stay, coordinated team preparation for discharge, a dedicated discharge appointment, and a follow up phone call.

Patients are admitted without a pre-determined discharge date. They do not receive a dedicated discharge appointment, and will not receive a follow up phone call 48 hours after discharge.

These patients will receive a pre-admission overview of their surgery, an anticipated discharge date, and a pre-scheduled discharge appointment to set patient expectations for a shorter hospitalization. On the day of discharge, the patient and his or her caregiver will attend an extended discharge appointment with a TCP-trained nurse. Finally, patients will receive a surveillance phone call 48 hours after discharge.

Transitional Care Programme

Alex Alamri, MBBS

Edward McKintosh, FRCS(SN),PhD

Edward McKintosh, FRCS,PhD

Christopher Uff, PhD,FRCS

Faith C Robertson, BS

William B Gormley, MD,MPH,MBA

Amin Elyas, MBBS,FRCS

Edward McKintosh, FRCS(SN) PhD

Readmissions increasingly serve as a metric of hospital performance, inviting quality improvement initiatives in both medicine and surgery. Recently, a readmission reduction program in the United States was associated with significantly shorter length of stay, earlier discharge, and reduced 30-day readmission after elective neurosurgery. These results underscore the importance of patient education and surveillance after hospital discharge, and it would be beneficial to test whether the same approach yields beneficial results in a different health system, the NHS. In this study, the investigators will replicate the Transitional Care Program (TCP) published by Robertson et al.(Journal of Neurosurgery 2017) with the goal of decreasing length of stay, improving discharge efficiency, and reducing readmissions in neurosurgical patients by optimizing patient education and post-discharge surveillance.

Discharge Program Process Abbreviations: AA: administrative assistant; MRN: medical record number; OT: occupational therapy; PT: physical therapy; and TCT = Transitional Care Team.

CLINIC (pre-enrolment)

* Patient has clinic visit with surgeon and is identified for surgery
* Surgeon identifies that the patient is eligible to participate in the program and consents the patient for enrolment.
* Patients will be given a written information sheet on the program, and will have the opportunity to receive the information via email as well.
* Their consent will be obtained in clinic; the use of interpreters will be used for individuals with special communication needs.

AFTER CLINIC

* Once individuals consent to be randomised into the study, their MRN will be given to the TCP nurse, who will randomise the patient into the control or intervention group using a random number generator.
* Patients randomised to the TCP will be given a pre-determined discharge date when they are called to schedule their operation. The anticipated discharge date will be determined by each surgeon's expected length of stay per procedure.
* AA provides brief intro to patient about the discharge pilot, including need for family member to be present to take patient home after appointment is complete. The surgery and discharge appointments are then booked.
* AA sends surgical letter (with anticipated length of stay and discharge appointment date/time) and discharge pilot postcard to patient via email or mail
* AA enters case and discharge information into NSU Discharge Calendar
* Transitional Care Team (TCT) checks NSU Discharge Calendar daily for scheduled cases and discharge appointments

ADMISSION (TCT)

* TCT monitors operating theatre regularly for post-op pilot patients and visits daily
* TCT updates Safety Round white boards with all discharge appointment information
* TCT sends daily dept. email, including PT/OT, with following day's discharge appointment details

ADMISSION (INPATIENT/OUTPATIENT TEAMS)

* Patient is deemed appropriate for impending discharge by neurosurgery team
* TCT updates Safety Rounds white board and discusses discharge checklist with care team.
* Inpatient team completes discharge summary
* Inpatient team completes take-away medication list by 4pm one day prior to discharge appointment
* Inpatient team rationalises the need for further blood tests (as part of standard medical treatment, not for study purposes).
* Inpatient team confirms PT/OT is complete
* Inpatient team completes discharge checklist and puts in letter tray in TCP Nurse office for collection

POST-DISCHARGE APPOINTMENT

* Staff nurse or ward sister discharges patient
* TCT pulls discharge medications from pharmacy for appointments
* Healthcare assistant or staff nurse transports patient to discharge appointment
* Discharge appointment checklist completed by TCT for appointment
* Volunteer transports patient to hospital exit or Discharge Lounge

AFTER POST-DISCHARGE APPOINTMENT

* TCT/volunteer scans signed discharge appointment checklist into medical record
* TCT/volunteer records data in the spreadsheet
* TCT/volunteer shreds checklists
* TCT communicates any outstanding issues to primary teams
* Patient is asked to complete a patient satisfaction survey which will be sent via post and email. A second request will be sent at one week and two weeks post discharge.

FOLLOW-UP PHONE CALLS

* After completion of post-discharge appointments, TCT makes follow-up phone calls
* Call template is completed
* Call template is scanned into medical record
* All outstanding issues will be signed out to the primary teams by the TCT

Outcome measures will be collected through:

Intake forms Longitudinal data collection from hospital medical records and patient satisfaction surveys.

Data collected will be 30-day unplanned hospital re-admissions (to the same institution as the index operation) and length of hospital stay, the latter of which will be evaluated continuously by the number of hours of the initial hospitalisation. Time of discharge (with an early discharge defined as before 12:00 PM) will also be recorded.

Patients will be randomised into two groups: standard of care or Transitional Care Programme (TCP)

All eligible patients will be consented to participate in the study. If they consent, a non-clinician study team member will randomise the patient into the control or intervention arm. Thereafter, all members of the care team will be notified of the patient's allocation in order to deliver the TCP.

Neurosurgical Transitional Care Programme

Transitional Care Services: A Quality and Safety Process Improvement Programme in Neurosurgery

Time from admission until discharge (reported in hours)

Early morning discharge (between 00:00 and 11:59)

Total cost of hospital admission, transitional care programme, and readmission

5-point Likert-scale scores will be analyzed from a single patient satisfaction survey that is provided to the patient at the time of discharge. This survey was reported previously by Robertson et al. (Journal of Neurosurgery, 2017). The patient will have 2 weeks to complete the survey. Scores will assess patient satisfaction with 1 being the least satisfied and 5 being the most satisfied. Scores will be averaged for analysis and reporting.

Brigham and Women's Hospital

Harvard Medical School (HMS and HSDM)

Barts & The London NHS Trust

Adjuvants, Anesthesia

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Midazolam

Intraoperative ultrasensitive Doppler acquisitions by using an ultrasound device for functional area detection

Ultrasensitive Doppler acquisition obtained with the Aixplorer ultrasound device

Ultrasound device

Dorian Chauvet, MD

A wide spectrum of methods is used to image brain activation in vivo. It can be directly detected by neurons electrical activity imaging (cortical simulation mapping, calcium imaging, voltage sensitive dyes) or indirectly by imaging hemodynamic changes induced by the neurovascular coupling in the vessels surrounding the activated neurons (intrinsic optical imaging, photoacoustic imaging, positron emission tomography (PET), functional magnetic resonance imaging (fMRI)).

Ultrasound as the potential to complement these functional imaging techniques at low cost. Ultrasound imaging can do real-time in-depth imaging of brain. However, its use to imaging of major vessels has been limited until now due to its poor sensitivity. To overcome this limitation functional ultrasound (fUS) was developed in Institut Langevin since 2011. This technique enables high spatio-temporal resolution imaging of whole-brain microvasculature dynamics in response to brain activation without the need of contrast agent.

This fUS method relies on a new power Doppler imaging sequence sensitive enough to detect blood flow in most of cerebral vessels (arterioles, big venules and larger vessels). Repeating the acquisition of such ultrasensitive Doppler images over time enables to follow flow dynamics in such vessels modulated by local neuronal activity.

Applied to the rat brain, fUS was proved able to map brain activation at high spatiotemporal resolution and high signal to noise ratio. The aim of this study is now to apply fUS on human brain in intraoperative condition.

The main objective of this study is to find activation maps through intraoperative ultrasensitive Doppler compared to gold standard cortical simulation mapping and functional MRI.

Secondly the investigators want to test sensitivity of this new Doppler mode. fUS method will be used for different types of stimuli and intensity and the investigators will do some control acquisitions. Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler to prove that this new Doppler mode enhance micro vessel visualization.

Intraoperative Functional Ultrasound

Doppler Ultrasonore Ultrasensible Peropératoire du Cerveau - Vers Une Aide Temps Reel à la Cartographie Corticale Fonctionnelle

fUS method will be tested for different types of stimuli and intensity and the investigators will do some control acquisitions.

Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler.

Institut National de la Santé Et de la Recherche Médicale, France

Infections

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Lymphoma

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Lymphoma, AIDS-Related

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Blood-Borne Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

Virus Diseases

RNA Virus Infections

Genital Diseases

Urogenital Diseases

Syndrome

Immunologic Deficiency Syndromes

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Lymphosarcoma

Primary Central Nervous System Lymphoma

B-cell Lymphoma

This study will evaluate the usefulness of two tests in quickly distinguishing whether a patient with HIV infection and focal brain lesions (an injury in a specific area of the brain) has a rare type of cancer called primary central nervous system lymphoma (PCNSL), or a parasitic infection called toxoplasmic encephalitis.

Toxoplasmic encephalitis is caused by a parasite and can be treated with antibiotics. PCNSL (lymphoma of the brain or spinal cord) must be definitively diagnosed with a brain biopsy (removal of a small piece of brain tissue), and the treatment is radiation therapy and chemotherapy.

The tests under study for diagnosing PCNSL or toxoplasmic encephalitis are measurement of Epstein Barr virus (EBV) DNA in cerebrospinal fluid (CSF) and FDG-PET scan of the brain. EBV is often found in the CSF of people with PCNSL. The study also will compare the accuracy of two imaging techniques-TI-SPECT and FDG-PET-in distinguishing between toxoplasmosis and PCNSL.

Patients 18 years of age and older who have HIV infection and at least one focal brain lesion without a prior history of PCNSL or toxoplasmic encephalitis may be eligible for this study. Each candidate is screened with a medical history, physical examination, blood and urine tests and MRI scans of the brain.

Upon entering the study, all participants take medication to treat toxoplasmic encephalitis. They undergo lumbar puncture (spinal tap) to obtain CSF for analysis, an FDG-PET scan, and a 201TI-SPECT scan. For the PET scan, a radioactive substance is injected into an arm, followed by scanning in a doughnut-shaped machine similar to a CT scanner. SPECT is similar to PET but uses a different radioactive tracer, and the patient lies on a table while the SPECT camera rotates around the patient's head. Patients whose test results indicate a low risk for lymphoma continue antibiotic therapy for toxoplasmosis. They have repeat MRI scans around 4, 7, and 14 days after starting the drug to monitor the response to therapy. Antiretroviral therapy is initiated in patients who are not already on such a regimen.

Patients whose test results indicate a high risk for PCNSL have a CT scan to look for evidence of lymphoma elsewhere in the body and are referred for consultation with a neurosurgeon to discuss undergoing a brain biopsy. The brain biopsy is done in the operating room under general anesthesia. A small cut is made in the scalp and a small opening is made in the skull over the area of the brain to be biopsied. A needle is placed in the opening in the skull and, guided by CT or MRI, moved to the abnormal area of the brain, where a small piece of tissue is removed for study under a microscope.

Patients found to have toxoplasmosis are discharged from the hospital to the care of their primary care physician after they are getting better and are tolerating all their medications. They return to NIH for follow-up visits about 4 weeks, and 6 months after discharge.

Patients found to have lymphoma are referred to the National Cancer Institute for screening for enrollment in a treatment protocol. Patients who are not eligible for a treatment protocol are referred back to their primary care physician or for another NIH treatment protocol, if one is available. Patients with lymphoma are seen at the NIAID outpatient clinic for follow-up visits and laboratory examinations every 3 months for 2 years.

Epstein Barr Virus (EBV)-associated primary central nervous system lymphoma (PCNSL) remains a major problem among AIDS patients. The clinical presentation is often clinically indistinguishable from toxoplasmic encephalitis. The method of choice for establishing the definitive diagnosis is brain biopsy. This procedure can be associated with a significant morbidity and mortality, and therefore less invasive means of diagnosing cerebral mass lesions have been studied.

Currently, an accepted standard of care for HIV-infected patients that present with signs and symptoms of focal brain lesions is to empirically treat for toxoplasmic encephalitis. Brain biopsy is often deferred until there is demonstration of lack of clinical response or progression on empiric therapy. As a result, treatment initiation is frequently delayed. During this time it is not unusual for further clinical deterioration to occur before appropriate therapies can be initiated. Frequently, the alternative approaches then become a question of appropriate palliation rather than curative intent therapy.

Less invasive diagnostic tests to assist in the diagnosis have been investigated. Based on the finding that essentially 100% of HIV-related PCNSL are EBV-associated, the detection of EBV DNA by PCR amplification in the cerebrospinal fluid (CSF) has demonstrated clinical usefulness in the diagnosis, as has the use of neuroradiologic imaging to detect the malignancy. Prior studies have demonstrated that the use of a combination of neuroradiologic, immunologic, and clinical variables in the workup of focal brain lesions in HIV-infected patients to be quite accurate in identifying patients in need of brain biopsy, but a diagnostic algorithm that incorporates the combination of the most sensitive and specific tests in a timely manner has not yet been explored.

This study seeks to evaluate an algorithm for the workup of HIV infected patients with focal brain lesions so as to expedite the diagnosis and subsequent treatment of PCNSL. The goals of the study are to 1) determine the specificity, sensitivity, and positive predictive value of a diagnostic algorithm that entails the use of the combination of EBV detection in the CSF and FDG-PET scanning to diagnose PCNSL; 2) evaluate the time to response to anti-toxoplasmic encephalitis therapy, and 3) evaluate the sensitivities and specificities of FDG-PET and (201)Tl-SPECT scanning in identifying PCNSL. Up to one hundred HIV-infected patients with history of at least one focal brain lesion will be screened for enrollment. All patients will be treated empirically for toxoplasmic encephalitis until an alternative diagnosis is confirmed. All enrolled patients will be treated concurrently with antiretroviral therapy. Patients identified to have PCNSL will be referred to the NCI Treatment of PCNSL Protocol for further treatment if the study is open for enrollment.

Evaluation of Brain Lesions in HIV-infected Patients for Diagnosis of Primary Central Nervous System Lymphoma

The Evaluation of Focal Contrast-Enhancing Brain Lesions in HIV-Infected Patients

National Institutes of Health Clinical Center (CC)

Brain Tumor, Adult

Maximum Grip Strength will be measured using a hand-held dynamometer (K-FORCE Grip dynamometer®. Kinvent Biomequanique S.A.S, Montpellier, France) during the preoperative, intraoperative (Awake craniotomy) and postoperative period.

Hand-held dynamometer

Kaisorn L Chaichana, M.D.

Lina C Marenco-Hillembrand, M.D.

Kaisorn Chaichana, MD

The primary purpose of this study is to assess the feasibility, safety and reliability of the use of handheld dynamometry in evaluating intraoperative motor function for patients undergoing awake craniotomy for the resection of brain lesions located within or adjacent to the motor cortex.

Handheld Dynamometer During Awake Craniotomy Pilot

Use of Handheld Dynamometer as a Novel Tool to Assess Motor Function During Awake Craniotomy for Brain Lesions Located Within or Adjacent to the Motor Cortex: A Single-Center Pilot Study

Maximum grip strength (KgF) will be measured using hand-held dynamometry every 2 minutes from the time the patient awakes until the end of surgery. Intraoperative maximum grip strength baseline is defined as the mean of 3 consecutive measures with \<10% variability.

To validate the use of hand-held dynamometry as an adequate tool to monitor intraoperative motor function during awake craniotomies (AC), maximum grip strength (KgF) will be measured every 2 minutes from the time the patient awakes to the end of surgery. The intra-individual variability will be defined as the percent difference between sets with 10% or greater defined as substantial variability.

To validate the use of hand-held dynamometry as an adequate tool to monitor intraoperative motor function during AC, each patient will be baselined (mean of 6 consecutive measurements) during the preoperative neuropsychology evaluation. Variability from preoperative baseline will be calculated as a percentile \[ (Preoperative Baseline/ Intraoperative Baseline)/ Preoperative Baseline) \* 100\]

Defined as the duration of the procedure from the initiation of skin incision to the completion of skin closure according to anesthesia records. Measured in minutes.

Concordance between hand-held dynamometer and manual motor testing will be evaluated using Spearmans' correlation coefficient.

Postoperative Maximum Grip strength (KgF) will be measured using hand-held dynamometer at day 1 and at 1 month follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiologic Pathologic Correlation of Advanced MR Imaging to Guide the Biopsy of Cerebral Malignancies	NCT03458676	Brain Lesion	Advanced Magnet... Standard of Car...	18 Years -	M.D. Anderson Cancer Center
Neurosurgical Transitional Care Programme	NCT03593330	Surgery Brain Tumor Brain Tumor, Re... Brain Pathology Spinal Diseases Spinal Stenosis Spinal Fusion Trigeminal Neur... Hydrocephalus Fusion of Spine Aneurysm SPINAL Fracture Chiari; Net Skull Injuries Brain Cancer Brain Metastase... Brain Diseases Brain Lesion Brain Cyst Spinal Curvatur... Spinal Instabil... Spinal Cord Neo...	Transitional Ca...	-	Barts & The London NHS Trust
Intraoperative Functional Ultrasound	NCT02656407	Brain Tumor Brain Lesion	Ultrasound devi...	18 Years -	Institut National de la Santé Et de la Recherche Médicale, France
Evaluation of Brain Lesions in HIV-infected Patients for Diagnosis of Primary Central Nervous System Lymphoma	NCT00226304	HIV Infections Lymphoma, AIDS-...		18 Years -	National Institutes of Health Clinical Center (CC)
Evaluation of Brain Lesions in HIV-infected Patients for Diagnosis of Primary Central Nervous System Lymphoma	NCT00226304	HIV Infections Lymphoma, AIDS-...		18 Years -	National Institutes of Health Clinical Center (CC)
Handheld Dynamometer During Awake Craniotomy Pilot	NCT04742231	Brain Lesion Brain Tumor Adu... Brain Tumor	Hand-held dynam...	18 Years -	Mayo Clinic
Neurosurgical Transitional Care Programme	NCT03593330	Surgery Brain Tumor Brain Tumor, Re... Brain Pathology Spinal Diseases Spinal Stenosis Spinal Fusion Trigeminal Neur... Hydrocephalus Fusion of Spine Aneurysm SPINAL Fracture Chiari; Net Skull Injuries Brain Cancer Brain Metastase... Brain Diseases Brain Lesion Brain Cyst Spinal Curvatur... Spinal Instabil... Spinal Cord Neo...	Transitional Ca...	-	Barts & The London NHS Trust
Evaluation of Brain Lesions in HIV-infected Patients for Diagnosis of Primary Central Nervous System Lymphoma	NCT00226304	HIV Infections Lymphoma, AIDS-...		18 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for brain lesion

Every month we try and update this database with for brain lesion 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.