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A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor

Primary Purpose

Brain Tumor, Metastatic Brain Tumor

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Resting-state functional connectivity MRI

Neurocognitive battery with quality-of-life assessment

About this trial

This is an interventional diagnostic trial for Brain Tumor focused on measuring Proton Beam Radiotherapy (PBRT), Cognitive battery assessment, Quality of life assessment

Eligibility Criteria

6 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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 21 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 21 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.

Sites / Locations

Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

patients

healthy matched controls

Arm Description

A full neurocognitive battery with quality-of-life assessment will be conducted and an rs-fcMRI sequence will be added to the brain MRI performed as standard of care follow-up between 3-5 months post-PBRT.

Healthy participants will be asked to complete the MRI scan and undergo neurocognitive assessment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05288439

First Posted

March 8, 2022

Last Updated

June 7, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05288439

Brief Title

A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor

Official Title

Neuroimaging Biomarkers of Impaired Neurocognitive Functioning After Cranial Proton Beam Radiotherapy For Treatment of Brain Tumors In Pediatric Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 7, 2022 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Tumor, Metastatic Brain Tumor

Keywords

Proton Beam Radiotherapy (PBRT), Cognitive battery assessment, Quality of life assessment

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This prospective, cross-sectional, pilot clinical trial will incorporate rs-fcMRI and a full post- PBRT cognitive battery including quality of life assessment for pediatric patients using a multidisciplinary team.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patients

Arm Type

Experimental

Arm Description

Arm Title

healthy matched controls

Arm Type

Experimental

Arm Description

Healthy participants will be asked to complete the MRI scan and undergo neurocognitive assessment.

Intervention Type

Diagnostic Test

Intervention Name(s)

Resting-state functional connectivity MRI

Intervention Description

participants will undergo functional MRI

Intervention Type

Other

Intervention Name(s)

Neurocognitive battery with quality-of-life assessment

Intervention Description

Cognitive and quality of life assessments performed by a trained neuropsychologist

Primary Outcome Measure Information:

Title

differences in the resting state brain networks of children and young adults

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrei Holodny, MD

Phone

212-639-3182

holodnya@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Stephen Sands, PsyD

Phone

646-888-0023

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrei Holodny, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrei Holodny, MD

Phone

212-639-3182

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor

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