NCT01212731

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2017

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

5 years

First QC Date

September 28, 2010

Last Update Submit

April 7, 2020

Conditions

MalignancyGliomaRadiotherapy

Keywords

Patients with malignancies of the skull base or patients with low grade glioma who require radiotherapy.

Outcome Measures

Primary Outcomes (1)

  • Neurocognitive evaluation

    verbal and visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression

Secondary Outcomes (1)

  • Advance MRI imaging

Study Arms (2)

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 plansRadiation: Proton Treatment PlansBehavioral: Neurocognitive evaluationDevice: Advanced MRI imaging

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 evaluationDevice: Advanced MRI imaging

Interventions

Photon treatment plansRADIATION

10 of the 30 subjects on Cohort 1 will receive photon treatment plans.

Cohort 1
Proton Treatment PlansRADIATION

20 subjects from Cohort 1 will receive proton treatment plans with malignancies involving the base of skull.

Cohort 1
Neurocognitive evaluationBEHAVIORAL

Verbal and Visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression.

Cohort 1Cohort 2
Advanced MRI imagingDEVICE

Anatomic Imaging, Blood volume measurements, Diffusion Tensor Imaging, DTI Image Processing

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.
  • 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.
  • +2 more criteria

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

NeoplasmsGlioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Michelle Alonso Basanta, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2010

First Posted

October 1, 2010

Study Start

September 1, 2010

Primary Completion

August 31, 2015

Study Completion

October 17, 2017

Last Updated

April 8, 2020

Record last verified: 2020-04

Locations

US(1)