Neoplasms

All Conditions

Nervous System Diseases

Head and Neck Neoplasms

Brain Neoplasms

Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures.

Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago.

Healthy patients who are matched to Stratum A patients

Radiation Therapy with substructure informed planning determined by the PI.

substructure informed planning

California Verbal Learning Test (CVLT) and other cognition assessments.

Neurocognitive Testing

Magnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI).

Sahaja Acharya, MD

Katie Lowe

The goal of this trial is to determine whether it is possible to minimize radiation dose to parts of the brain that are important for thinking and learning in children who require radiation to treat their tumor, and if this will help reduce neurocognitive (thinking and learning) impairments in these patients.

Patients with newly diagnosed brain or head and neck tumors who are having radiation therapy will have neurocognitive testing and MRI imaging (both research and for regular care) done as part of their participation in the study.

Survivors of childhood brain tumors who completed radiation therapy at least two years before joining the study, and have not had a recurrence, will have neurocognitive testing and research MRIs completed.

Healthy children will also be enrolled and have research MRIs done.

The researchers will use the radiation plan to determine how much radiation was delivered to different parts of the brain. The investigators will use the MRIs to determine how the normal brain is changing after treatment; and how this compares to patients who had standard radiation treatment or who never had a brain tumor. The neurocognitive testing will be compared among different groups to see how different treatment plans affect performance on neurocognitive tests.

Stratum A: patients with new diagnosis of brain or head and neck cancer who will be undergoing radiation therapy with substructure informed planning

Stratum B: patients ≥ 2 years from radiation therapy for brain tumor who underwent standard planning radiation therapy

Stratum C: healthy controls matched to Stratum A patients

Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients

Number of plans that meet substructure-informed constraints (per protocol) divided by the total number of plans.

Calculate the cumulative incidence of local and distant tumor recurrence. Local and tumor recurrence is determined by imaging and clinical symptoms.

This outcome will measure changes in connection strength within brain networks. Fractional anisotropy values range from 0 to 1. Higher numbers are better.

Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.

United States Department of Defense

Clark Charitable Foundation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Behaviors and Mental Disorders

Rare Diseases

Cognitive Dysfunction

Cognition Disorders

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Tumor, Childhood

* Prior to surgery, subjects will have a complete standard of care history and physical exam by the neurosurgeon and then undergo peri-diagnostic neurocognitive testing utilizing the NIH Toolbox Cognitive Battery computer testing software for iPad (will take 45 minutes). The peri-diagnostic period will be defined as the period from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later.
* Participants will also undergo a rsfcMRI during their standard of care MRI imaging which will add 15 minutes to their scan time

* Patients with diagnosis of a posterior tumor will undergo neurocognitive testing utilizing the NIH Toolbox. Testing will be every 6 months for children currently receiving therapy and annually for those that have completed all therapy for a total of 3 sessions. During standard of care MRI images, rsfcMRI imaging will be performed which will add 15 minutes of time. rsfcMRI will be obtained every 6 months for children currently receiving therapy and annually for those that have completed therapy for a total of 3 rsfcMRIs for each patient.
* Patients in Cohort 1 will also be eligible to continue with the longitudinal assessment as just described. These participants will then undergo repeat neurocognitive testing using the NIH toolbox 6-9 months for an additional 3 testing sessions. rsfcMRI will be obtained during their follow-up imaging at 6-9 month intervals for a total of 3 additional rsfcMRIs (4 total scans).

* During standard of care MRI images, rsfcMRI imaging will be performed which will add 15 minutes of scan time.
* rsfcMRI will be obtained annually for total of 3 rsfcMRIs for each patient.

Undergo the following MRI images: RSFC MRI, T2/T1 MRI, and DTI.

* Will complete cognitive testing using the NIH Toolbox Cognitive Battery
* All patients will complete the Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale - 5 questionnaire. All patients will complete a self-reported assessment of neurological quality of life (QOL). Adult patients (age ≥ 18 years) will complete the adult version of the Quality of Life in Neurological Disorders (Neuro-QOL) Cognitive Function measure. All pediatric patients will complete the pediatric version of the Neuro-QOL Cognitive Function measure. For patients \<18 years of age and for adult patients with parent present, parent/caregiver will complete the PROMIS® Parent Proxy for cognition. All adult patients will complete the Colorado Learning Difficulties Questionnaire (CLDQ). This questionnaire will be completed by parent/caregiver for patients \< 18 years of age.

* During standard of care MRI images, rsfcMRI imaging will be performed which will add 15 minutes of scan time.
* Will complete cognitive testing using the NIH Toolbox Cognitive Battery
* All patients will complete the Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale - 5 questionnaire. All patients will complete a self-reported assessment of neurological quality of life (QOL). Adult patients (age ≥ 18 years) will complete the adult version of the Quality of Life in Neurological Disorders (Neuro-QOL) Cognitive Function measure. All pediatric patients will complete the pediatric version of the Neuro-QOL Cognitive Function measure. For patients \<18 years of age and for adult patients with parent present, parent/caregiver will complete the PROMIS® Parent Proxy for cognition. All adult patients will complete the Colorado Learning Difficulties Questionnaire (CLDQ). This questionnaire will be completed by parent/caregiver for patients \< 18 years of age.

Neurocognitive testing

The imaging protocols will be a combined version of a standard of care (SOC) protocol with a research portion. The SOC portion of the pre-surgical scans includes a 3D T2-weighted (T2w) scans and 3D pre- and post-contrast T1-weighted (T1w) images, both at high resolution (1.0 mm3) for use in the intraoperative navigation system. This scan also includes a DTI portion for definition of fiber bundles of interest. The SOC portion of the post-surgical scans includes transverse FLAIR and post-contrast T1w images in all 3 planes. The research portion of the scan will be identical at all 3 time points and include 15 min of rsfcMRI during which the non-sedated subjects will be asked to stay still and awake while looking at a fixation cross

rsfcMRI

Stephanie Perkins, M.D.

Scott Marek, Ph.D.

David Limbrick, M.D., Ph.D.

Joshua Shimony, M.D., Ph.D.

Josh Rubin, M.D., Ph.D.

Dennis Barbour, M.D., Ph.D.

The investigators will focus on three cohorts of brain tumor patients aged, 4-18 years, to answer two critical questions: 1) Can the investigators acquire high quality data relevant to cognitive function during the peri-diagnostic period and, 2) can the investigators develop predictive models for cognitive outcomes using serial examination of functional imaging and cognitive function. Any patient with a newly diagnosed brain tumor aged 4-18 will be eligible for enrollment in cohort 1. Only patients with previously diagnosed tumors of the posterior fossa will be eligible for cohort 2. For cohort 3, eligible patients will include patients with a clinical diagnosis of posterior fossa syndrome with physical impairments that prohibit completion of the NIH Toolbox Cognitive Battery. The investigators have decided to expand the eligible tumor types to better capture the most significant deficit variability that can be caused by tumors outside the posterior fossa. Thus, this focus will provide a platform to analyze the impact that different tumor types and different standard treatments have on cognitive dysfunction. The rationale for inclusion of subjects on cohort 3 is that posterior fossa syndrome is one of the most cognitively devastating diagnoses following a posterior fossa surgery. The causes of posterior fossa syndrome and unknown and there are currently no interventions to improve symptoms. RsfcMRI would offer a novel and non-invasive assessment of posterior fossa syndrome patients by assessing connectivity within and outside of the cerebellum. Expanding the tumor eligibility will allow us to further explore the effect tumor location will have on cognitive testing and rsfcMRI. Here, repeated evaluations on and off therapy will provide the necessary data points to establish trajectories of cognitive development and recovery in this population.

Cognitive Biomarkers in Pediatric Brain Tumor Patients

As dictated by information theory, properly combining predictors across modalities must increase the accuracy of the prediction algorithm, unless a given modality contains no information about the question of interest (in this case, long-term cognitive outcomes).

Children's Discovery Institute

Neurosurgery Research & Education Foundation

The Andrew McDonough B+ (Be Positive) Foundation

Washington University School of Medicine

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Multiple Myeloma

Neoplasms, Plasma Cell

Pain

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Patients diagnosed with multiple myeloma (MM) complete questionnaires with Neurocognitive Testing and Neurosensory Testing

Questionnaires measuring pain and other symptoms, mood, and quality of life.

Questionnaire

A neurocognitive exam (tests to check your memory and thinking abilities, for example) will be performed.

Neurosensory testing will be performed to find out how sensitive you are to things such as touch, coolness, warmth, pinprick on the finger, and squeezing of the skin on the finger, hand, or arm.

Neurosensory Testing

Xin Shelley Wang, MD

The goal of this research study is to learn about the pain and/or other symptoms that patients may experience either while you are being monitored by your doctor before a decision is made to start you on treatment for your MM, or during and after treatment for MM, and how these symptoms may affect therapy. A second goal is to learn how differences in genes may affect the symptom burden from cancer and cancer therapy.

If you agree to take part in this study, you will complete 5 questionnaires during a regularly scheduled clinic visit. These questionnaires will measure pain and other symptoms, such as your mood and quality of life. You will also be asked to give a tissue sample by inserting a swab into your mouth and rubbing firmly against the inside of your cheek or underneath your lower or upper lip for about a minute at most. Completing the 5 questionnaires and the swab sample collection takes about 30 minutes in total.

This is an investigational study.

Up to 500 patients will take part in the cross-sectional phase of this study. All will be enrolled at MD Anderson.

Tissue sample by inserting a swab into mouth and rubbing firmly against the inside of cheeck or underneath lower or upper lip for about a minute during a regularly schedule clinic visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients	NCT05658731	Brain Tumor Head and Neck C...	substructure in... Neurocognitive ... MRI	1 Year - 26 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Cognitive Biomarkers in Pediatric Brain Tumor Patients	NCT02914067	Childhood Brain...	Neurocognitive ... rsfcMRI	4 Years - 18 Years	Washington University School of Medicine
Cognitive Biomarkers in Pediatric Brain Tumor Patients	NCT02914067	Childhood Brain...	Neurocognitive ... rsfcMRI	4 Years - 18 Years	Washington University School of Medicine
Cognitive Biomarkers in Pediatric Brain Tumor Patients	NCT02914067	Childhood Brain...	Neurocognitive ... rsfcMRI	4 Years - 18 Years	Washington University School of Medicine
Inflammatory Cytokines in Symptom Production in Multiple Myeloma	NCT00688168	Multiple Myelom...	Questionnaire Neurocognitive ... Neurosensory Te...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for neurocognitive testing