Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study

April 7, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania

Detection of Vascular and Neuronal Changes Following Proton and/or Photon Radiotherapy in Patients Receiving Skull Base and/or Brain Radiation

The purpose of this study is to:

  • estimate the degree of memory loss, if any following radiotherapy to the base of skull or brain as measured by standard neurocognitive battery testing.
  • describe radiotherapy dose-related changes in vascular perfusion, in spectroscopic parameters of neuronal injury and changes in the degree and directionality of tissue water diffusivity (diffusion tensor imaging) as a measure of white axonal injury.
  • to relate these imaging characteristics to the degree of memory loss.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Data suggests that regions of the normal brain exposed to radiation doses that has otherwise been regarded as safe and not limited by current radiation treatment planning may contribute to the risk of late neurocognitive injury. Radiation dose-dependent subclinical vascular effects have been reported in irradiated normal brain tissue and have been hypothesized to be a potential mechanism of action. Direct neuronal injury is another potential mechanism of injury. 1)Estimate the degree of cognitive loss following RT. 2) Demonstrate evidence of radiation induced subclinical vascular and neuronal injury in adjacent brain regions receiving exit doses of radiation. Subjects will include patients with malignancies of the skull of the skull base or patients with low grade glioma who require radiotherapy. Baseline MRI imaging of the brain utilizing established techniques will be used to identify and characterize the regions of interest anatomically adjacent to the regions of intended high dose irradiation. The MRI data for the ROIs will be registered with the radiotherapy treatment planning CT in order to create a single volume of data where each voxel corresponds to a vector containing the multi-parametric information. Subsequent repeat MRI imaging will be at 1.5, 4.5, 12 and 24 months following completion of the radiotherapy for patients with low grade glioma and 1.5 and 12 months post radiotherapy for patients with malignancies involving the skull base. Both cohorts will repeat standard neurocognitive evaluation at 1.5, 4.5,12 and 24 months following completion of radiotherapy. Analysis: Neurocognitive domains will be evaluated at the designated time points.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Eligible subjects will include patients with malignancies of the skull base or patients with low grade glioma who require radiotherapy. 10 subjects receiving photon treatment plans and 20 subjects receiving proton treatment plans with malignancies involving the base skull and a total of 40 patient with low grade glioma will be prospectively enrolled.

Description

Inclusion Criteria: For Cohort 1 (Patients with tumor involving the base of skull)

  • Study subjects capable of providing informed consent.
  • Study subjects with an ECOG performance status of 0-1.
  • Study subjects aged 18 or greater.
  • Study subjects with a histological diagnosis of a malignancy of the paranasal sinuses or the nasopharynx requiring either definitive or post-operative radiation to a minimum prescribed dose of 60 Gy.
  • Study subjects deemed capable of undergoing standard CT simulation and radiotherapy treatment planning and delivery including the capacity to comply with standard immobilization devices to the head and nexk for daily irradiation.
  • Study subjects without any evidence of distant metastasis.
  • Study subjects with an estimated life expectancy of at least 1 year.
  • Study subjects who are able to receive a standard MRI study and deemed capable of complying with the immobilization needs.
  • Female study subjects of reproductive potential with a negative pregnancy test prior to each scheduled MRI study.

Inclusion Criteria: For Cohort 2 (Patients with Low Grade Gliomas)

  • Histological confirmed diagnosis of low grade glioma of the CNS
  • WHO grade II
  • Patients must have a Karnofsky Performance Status of greater than or equal to 60.
  • Age greater than or equal to 18.
  • Patients must be able to provide informed consent.
  • Adequate bone marrow function:WBC greater than or equal to 4000/mm3, platelets greater than or equal to 100,000 mm3.
  • Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms, or other barrier methods, etc.). Hysterectomy or meopause must be clinically documented.
  • Study subjects deemed capable of undergoing standard CT simulation and radiotherapy treatment planning and delivery including the capacity to comply with standard immobilization devices to the brain for daily irradiation.

Exclusion Criteria: for Both Cohorts

  • Study subjects with questionable performance status and in whom the treating physician is suspicious that a life expectancy of at least 1 year is possible.
  • Study subjects with anxiety that precludes the safe administration of a MRI for the imaging time required.
  • Study subjects with major psychiatric diagnosis prior to neuro-oncologic diagnosis.
  • For neuropsychological studies, study subjects with neurological or behavioral issues that would preclude compliance with study procedures. (Karnofsky Performance Scale score of less than 60, indicating that the patients needs considerable assistance for self care and frequent medical care).
  • Study subjects with an inability to undergo MR Imaging for any reason.
  • Study subjects with a history of renal transplant or known renal disorder with a calculated GFR > 45mL/1min [gadolinium restriction]
  • For neuropsychological studies, study subjects with mixed language background with only one year of educationin an English-speaking school.
  • Pregnant women, women planning to become pregnant and women who are nursing.

Additional Exclusion Criteria for Cohort 2 (Patients with Low Grade Gliomas)

  • Prior or simultaneous malignancies within the past two years (other than cutaneous squamos or basal cell carcinoma, melanoma in situ or well differentiated thyroid carcinoma).
  • Patients with the following histologies are excluded: Gliomatosis cerebri, WHO III or IV gliomas.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1
Subjects with a histological diagnosis of malignancy of the base of skull necessitating irradiation to a minimum of 60 Gy, ECOG PS 0-1 with no evidence of metastatic disease and an estimate life expectancy of at least 1 year and who is able to provide informed consent. Subjects will undergo standard CT simulation and radiotherapy treatment planning.
Radiation: Photon treatment plans
10 of the 30 subjects on Cohort 1 will receive photon treatment plans.
Radiation: Proton Treatment Plans
20 subjects from Cohort 1 will receive proton treatment plans with malignancies involving the base of skull.
Behavioral: Neurocognitive evaluation
Verbal and Visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression.
Device: Advanced MRI imaging
Anatomic Imaging, Blood volume measurements, Diffusion Tensor Imaging, DTI Image Processing
Cohort 2
Subjects with a histological diagnosis of low grade glioma requiring radiotherapy. ECOG PS 0-1 with no evidence of metastatic disease and an estimated life expectancy of at least 1 year and who is able to provide informed consent. Subjects will undergo standard CT simulation and radiotherapy treatment planning.
Behavioral: Neurocognitive evaluation
Verbal and Visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression.
Device: Advanced MRI imaging
Anatomic Imaging, Blood volume measurements, Diffusion Tensor Imaging, DTI Image Processing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Neurocognitive evaluation
verbal and visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Advance MRI imaging
Anatomic Imaging, Blood volume measurements, Diffusion Tensor Imaging, DTI Image Processing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abramson Cancer Center of the University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle Alonso Basanta, MD, Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 17, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UPCC 08310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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