A Pilot Study to Evaluate Neurocognitive Injury and Longitudinal Changes in White Matter During Radiation Therapy in Children With Primary Brain Tumors

NCT02006407 | Terminated Results DMC

• 1 other identifier: UMCC 2012.117
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to assess the changes in white matter, in the brain, in response to radiation therapy and correlate these changes with later declines in cognitive function.

Conditions

Brain Tumor, Primary

Outcome Measures

Primary Outcomes (1)

• Evaluate the Change From Baseline in Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging (DTI) at 3 Weeks and at 6 Weeks Post Radiation Therapy.

  Descriptive statistics and plots will be used to determine Diffusion Tensor Imaging (DTI) parameters for various regions in the brain. The mean (across subject) change in DTI parameter for a given region, at a given time, will be used to assess white matter injury.

  Baseline, 3 weeks, and 6 weeks

Secondary Outcomes (2)

• Evaluate the Correlation Between Global COGState Scores and the Perpendicular Diffusivity of Water by Diffusion Tensor Imaging at Baseline, 3 Weeks, and 6 Weeks Into Treatment.

  Baseline, 3 weeks, and 6 weeks

• Evaluate the Correlation Between Global COGState Scores, Radiation Dose, and the Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging at 6 Months

  6 months

Study Arms (1)

Primary Brain Tumor

OTHER

Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).

Radiation: Cranial Radiotherapy; Device: MRI with Diffusion Tensor Imaging (DTI); Behavioral: Neuro-cognitive Testing (CogState)

Interventions

Cranial Radiotherapy RADIATION

Standard cranial radiotherapy administered dependent upon patient and brain tumor type.

Primary Brain Tumor

MRI with Diffusion Tensor Imaging (DTI) DEVICE

Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)

Primary Brain Tumor

Neuro-cognitive Testing (CogState) BEHAVIORAL

CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests.

Primary Brain Tumor

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients (age 6-21) who will receive cranial radiotherapy for brian tumors. This could include but is not limited to: low grade glioma, high grade glioma (to include grade III but not grade IV glioma), germ cell tumors, primitive neuroectodermal tumors, craniopharyngioma, or medulloblastoma.
• Patients should, in the estimate of the treating physician, be anticipated to have a median survival of greater than 1 year.

You may not qualify if:

• Patients with previous Central Nervous System (CNS) radiation or or CNS tumors that, in the judgement of the investigators, are likely to undergo progression during or shortly after radiotherapy are excluded.
• Patients with glioblastoma, multiforme, gliosarcoma, diffuse pontine glioma, or other tumors presumed to have expected median survival per the investigators of less than 1 year.
• Patients who require sedation for Magnetic Resonance Imagining (MRI)are excluded.
• Patients at risk for nephrogenic systemic sclerosis will be excluded as a safety precaution due to the contrast used in the scans.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Results Point of Contact

• Title: Dr. Carl Johannes Koschmann, M.D.
• Organization: University of Michigan Comprehensive Cancer Center

ckoschma@umich.edu

734-647-2893

Study Officials

• Carl Koschmann, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 10, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 30, 2016
• Results First Posted: October 27, 2016

Record last verified: 2016-11

Locations

US (1)