MalignancyNCT01212731
Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
An observational study of Malignancy and Glioma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancy, Glioma, Radiotherapy
- What is being tested?
- Photon treatment plans, Proton Treatment Plans and Neurocognitive evaluation
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 17 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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]
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Malignancy, Glioma, Radiotherapy
- Being tested
- Photon treatment plans, Proton Treatment Plans, Neurocognitive evaluation, Advanced MRI imaging
- Keywords
- Patients with malignancies of the skull base or patients with low grade glioma who require radiotherapy.
- Medical subject headings
- Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon treatment plansRadiation
10 of the 30 subjects on Cohort 1 will receive photon treatment plans.
Proton Treatment PlansRadiation
20 subjects from Cohort 1 will receive proton treatment plans with malignancies involving the base of skull.
Neurocognitive evaluationBehavioural
Verbal and Visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression.
Advanced MRI imagingDevice
Anatomic Imaging, Blood volume measurements, Diffusion Tensor Imaging, DTI Image Processing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Photon treatment plans; Radiation: Proton Treatment Plans; Behavioral: Neurocognitive evaluation; Device: 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. Receives: Behavioral: Neurocognitive evaluation; Device: Advanced MRI imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Anatomic Imaging, Blood volume measurements, Diffusion Tensor Imaging, DTI Image Processing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startSep 2010
- Primary completion31 Aug 2015
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Michelle Alonso Basanta, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212731
- Sponsor's protocol ID
- UPCC 08310
- Status last verified
- Apr 2020
- First submitted
- 28 Sep 2010
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Vascular and Neuronal Changes Following Proton and/or Photon Radiotherapy in Patients Receiving Skull Base and/or Brain Radiation
- ClinicalTrials.gov ID
- NCT01212731
- Acronym / sponsor ID
- UPCC 08310
- Conditions
- Malignancy, Glioma, Radiotherapy
- Keywords
- Patients with malignancies of the skull base or patients with low grade glioma who require radiotherapy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2010
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 1 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Radiation: Photon treatment plans, Radiation: Proton Treatment Plans, Behavioral: Neurocognitive evaluation, Device: Advanced MRI imagingSubjects 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. |
| Cohort 2 | – | Behavioral: Neurocognitive evaluation, Device: Advanced MRI imagingSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photon treatment plans10 of the 30 subjects on Cohort 1 will receive photon treatment plans. | Radiation | Cohort 1 |
| Proton Treatment Plans20 subjects from Cohort 1 will receive proton treatment plans with malignancies involving the base of skull. | Radiation | Cohort 1 |
| Neurocognitive evaluationVerbal and Visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression. | Behavioural | Cohort 1, Cohort 2 |
| Advanced MRI imagingAnatomic Imaging, Blood volume measurements, Diffusion Tensor Imaging, DTI Image Processing | Device | Cohort 1, Cohort 2 |
Primary outcome
Neurocognitive evaluation
verbal and visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression
1 secondary outcome
Advance MRI imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Alonso Basanta, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignancy and Glioma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive evaluation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.