Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients

Brain Tumor, Primary Clinical Trial

Official title:

Assessing Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06185686
• Other study ID #: 202312104
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: Stephanie Perkins, M.D.
• Phone: 314-747-4405
• Email: sperkins[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With modern therapy, the survival rate for pediatric brain tumor patients has significantly improved, with over 70% of patients surviving their disease. However, this progress often comes at the cost of substantial morbidity, with cognitive deficits being the primary obstacle to independent living. Robust predictors of cognitive decline and a comprehensive understanding of the underlying mechanisms of cognitive injury remain elusive. This study will prospectively investigate alterations in brain resting state networks following radiation therapy using functional imaging. The hypothesis is that radiation therapy leads to dose-dependent alterations in functional connectivity in the networks associated with higher level cognition, ultimately leading to cognitive decline.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

Inclusion Criteria:

• Between 8 and 21 years of age, inclusive
• Newly diagnosed primary brain tumor of any location and any histology that will be treated with proton radiation therapy
• Life expectancy of at least one year
• Able to understand and willing to consent or assent to the research proposed (or that of a legally authorized representative, if applicable), along with consent of legal guardian(s) if applicable

Exclusion Criteria:

• Presence of visual impairment to an extent that the patient is unable to complete the computer testing
• Contraindication to MRI scan (i.e. due to cardiac pacemaker)
• Presence of programmable shunt or dental braces
• Requires sedation for MRI scans

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor, Primary

Intervention

Other:
• Cognitive testing
NIH Toolbox Cognitive Battery and the Novel Cognitive Measure (NCM)

Device:
• Resting State MRI/Precision functional mapping
At baseline (before the end of radiation therapy) and approximately 12 months after the completion of radiation therapy.

Locations

Country	Name	City	State
United States	Washington University School of Medicine/Saint Louis Children's Hospital	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	The Foundation for Barnes-Jewish Hospital, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation induced effects on functional brain resting state connectivity	The investigators will compare resting state maps of each patient pre- and post-radiation therapy. The investigators will evaluate changes in the resting state architecture and compare to the average results that would be expected from a patient in the same age and sex.	Through 1 year follow-up
Primary	Baseline characteristics of functional network architecture	The investigators will assess the unique architecture of brain networks at diagnosis and how significantly this architecture diverges from average healthy controls.	At baseline (day 1)
Primary	Change in characteristics of functional network architecture	The investigators will assess brain system segregation which is measure of the connection and disconnection between different brain networks. These will be compared within individuals and compared to healthy controls.	Baseline and 1 year follow-up
Secondary	Correlation of radiation dose to changes in cognitive performance and resting state network connectivity	In an exploratory fashion, the investigators will evaluate the dose of radiation received to each resting state network to determine if functional connectivity changes in a dose dependent manner at 1 year.	At 1 year follow-up

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine