Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05288439
Other study ID # 22-061
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 7, 2022
Est. completion date March 2025

Study information

Verified date June 2024
Source Memorial Sloan Kettering Cancer Center
Contact Andrei Holodny, MD
Phone 212-639-3182
Email holodnya@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The researchers are doing this study to find out if there are differences in the resting state brain networks of children and young adults (ages 6-25) after treatment with proton beam radiation therapy (PBRT). The researchers will use resting state functional connectivity magnetic resonance imagining (rs-fcMRI) scanning to detect these differences. The researchers will also check for differences in participants' thinking and quality of life through a cognitive assessment and a questionnaire. Both people undergoing PBRT for a brain tumor and healthy people will take part in this study so that the researchers can compare the brain networks (connections in the brain that are involved in certain function, such as memory or attention), thinking patterns, and quality of life of these two groups of participants. The study researchers think that rs-fcMRI scans may be an effective way to look at the brain networks after treatment with PBRT and see if this treatment causes differences in those networks, including damage to the brain (neurotoxicity). rs-fcMRI scans take images when a patient is in a resting state, which means the patient is not performing a task or thinking about anything in particular. This study will provide valuable information about how PBRT affects brain networks, thinking (cognitive) abilities, and quality of life in children and young adults. The study results may have an impact on future treatment approaches for brain cancer and the use of PBRT in children and young adults.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 25 Years
Eligibility Inclusion Criteria: Patients Treated for Brain Tumors: - The patient has been diagnosed with a primary or metastatic brain tumor - The patient has been recommended to receive cranial PBRT for a primary or metastatic brain tumor - The patient is between the ages of 6 through 25 at time of consent - As per medical record or patient report (based on prior tolerance of MRI), the participant is able to tolerate MRI without sedation (i.e., general anesthesia). Patients will take medications as prescribed or directed by the patient's physician. If in accordance with their prescribed regimen, agents that may impact the CNS, such as benzodiazepines and/or antihistamines, should be avoided on the day of imaging and neurocognitive assessment. Healthy Control Participants: - The control has no major medical illness, as determined by medical interview by study physician - As per parent report, the control is between the ages of 6 through 25 at time of consent - As per parent report, the control is able to tolerate an MRI without sedation (i.e., general anesthesia). Participants should only take medications as prescribed or directed by their physician. They should not take additional medications, such as antihistamines, for the purpose of tolerating MR imaging. Exclusion Criteria: - As per self or parent report, the participant has completed any portion of the neuropsychological battery used in this study within the last year. - As per medical record or self or parent report, there is an existing diagnosis of intellectual disability and/or prior IQ testing that documents Full Scale IQ standard score <70 at baseline. - As per medical record, there is an existing diagnosis of psychiatric disorder or untreated mood disturbance, prior stroke or intracranial hemorrhage, or neurodegenerative disease. - The participant has an MRI contraindication (e.g., implanted ferromagnetic devices, claustrophobia) as per radiology clinical operating procedures. - As per self or parent report, non-fluency in English language as demonstrated by current educational placement in a non-English-speaking classroom setting.

Study Design


Intervention

Diagnostic Test:
Resting-state functional connectivity MRI
participants will undergo functional MRI
Other:
Neurocognitive battery with quality-of-life assessment
Cognitive and quality of life assessments performed by a trained neuropsychologist

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary differences in the resting state brain networks of children and young adults A single rs-fcMRI sequence will be added to the MRI performed as standard of care follow-up 3-5 months after completion of cranial PBRT in pediatric patients treated for brain tumors to assess for early post-PBRT network disruption.
Using resting state functional connectivity magnetic resonance imagining (rs-fcMRI) scanning to detect these differences.
1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05023434 - A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
Completed NCT04474678 - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!") N/A
Completed NCT02768389 - Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma Early Phase 1
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT03286335 - Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy N/A
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Recruiting NCT05358340 - Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions N/A
Recruiting NCT03276676 - [18F]Fluciclovine and [18F]FLT PET/CT Assessment of Primary High-Grade Brain Tumors Phase 2
Completed NCT02851355 - Follow-up Survey of Patients Who Were Treated for Medulloblastoma or Primitive Neuroectodermal Tumors of the Central Nervous in Norway
Completed NCT02409121 - A Novel Health Information Technology System (BMT Roadmap) for Pediatric BMT Patients and Caregivers N/A
Completed NCT02558569 - The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block Phase 4
Completed NCT02713087 - Vasopressor Effects in Anesthetized Patients Phase 4
Terminated NCT02674945 - Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase
Withdrawn NCT02165995 - Use of Navigated Transcranial Magnetic Stimulation (nTMS) in Generated Motor and Language Mapping to Evaluate Brain Recovery Following Surgery N/A
Completed NCT01171469 - Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Progressive Malignant Brain Tumor Phase 1
Withdrawn NCT01202539 - Real-time Assessment of Frameless Intrafraction Motion
Terminated NCT01044966 - A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma Phase 1/Phase 2
Completed NCT00760409 - Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MRI N/A
Completed NCT00503204 - Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour Phase 1