Brain NeoplasmsNCT01988675
MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier
An observational study of Brain Neoplasms, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This is a study to determine if Magnetic Resonance Imaging (MRI) techniques can detect early changes in white matter (in the brain) and the blood-brain barrier resulting from radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- Whole Brain Irradiation, Partial Brain Irradiation and Neuropsychological Testing
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2004to 3 Jun 2014
- 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: Patients receiving partial or whole brain radiation therapy
Who may be able to join
- Patients receiving partial brain irradiation for malignant or benign brain tumors (including low-grade gliomas, high-grade gliomas, malignant meningioma, pituitary adenomas, supratentorial meningioma, or craniopharyngiomas); or patients receiving whole brain irradiation for brain metastases.
- Patients must be 18 years of age or older
- Patients must sign a study specific consent form approved by the Institutional Review Board (IRB) of the University of Michigan prior to study entry.
- Patients must have a neurological function class 1 or 2 with a Karnofsky performance status (a scoring system used to quantify general well being and quality of life on a scale of 100 to 0) of greater than or equal to 70.
- Patients must have an expected life expectancy of greater than 6 months.
Who cannot join
- Patients with a history of major medical illness or psychiatric impairment which, in the investigator's opinion, will prevent administration of the protocol.
- Patients who have had prior external beam irradiation to the brain or head/neck area that will lead to overlap of the radiation field.
- Patients should have no contraindications to having a contrast enhanced Magnetic Resonance Imaging (MRI) scan.
- Prisoners are excluded.
- Pregnant women are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hosptial
Ann Arbor, Michigan, 48109
About this study
This is a study to determine if Magnetic Resonance Imaging (MRI) techniques can detect early changes in white matter (in the brain) and the blood-brain barrier resulting from radiation therapy.
Read the detailed description
Patients will be assigned to one of two groups based on the type of radiation they will be receiving: whole brain irradiation or partial brain irradiation. Patients will undergo Magnetic Resonance Imaging (MRI) assessments, neurocognitive testing (Quality of Life and Neuropsychological assessments), and clinical evaluation.
- Conditions
- Brain Neoplasms
- Being tested
- Whole Brain Irradiation, Partial Brain Irradiation, Neuropsychological Testing, Quality of Life Questionnaire, Magnetic Resonance Imaging (MRI) Assessments
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Brain IrradiationRadiation
Partial Brain IrradiationRadiation
Neuropsychological TestingBehavioural
Quality of Life QuestionnaireBehavioural
Magnetic Resonance Imaging (MRI) AssessmentsDevice
MRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images).
| Study group | Role | What they receive |
|---|---|---|
| Partial Brain Irradiation | Patients will receive partial brain irradiation for malignant or benign brain tumors as standard of care. Patients will also have MRI (Magnetic Resonance Imaging) scans and neuropsychological/QOL (Quality of Life Questionnaire) tests prior during and after RT (Radiation Therapy). Receives: Radiation: Partial Brain Irradiation; Behavioral: Neuropsychological Testing; Behavioral: Quality of Life Questionnaire; Device: Magnetic Resonance Imaging (MRI) Assessments | |
| Whole Brain Irradiation | Patients will receive whole brain irradiation for brain metastases as standard of care. Patients will also have MRI (Magnetic Resonance Imaging) scans and neuropsychological/QOL (Quality of Life Questionnaire) tests prior during and after RT (Radiation Therapy). Receives: Radiation: Whole Brain Irradiation; Behavioral: Neuropsychological Testing; Behavioral: Quality of Life Questionnaire; Device: Magnetic Resonance Imaging (MRI) Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Magnetic Resonance Imagining (MRI) with different radiation dose at different timepoints.
Linear mixed models will be used to relate Magnetic Resonance Imagining (MRI) changes and radiation dose.
Measured: Baseline, at 3 weeks on radiation therapy (RT) (partial brain irradiation only), last week of RT, 6 weeks post RT, 4 months post RT (whole brain irradiation only), 6 months post RT, 18 months post RT (partial brain irradiation only)
Secondary outcomes (1)
Associate changes in Magnetic Resonance Imagining (MRI) assessments with changes in neurocognitive function and clinical symptoms, from baseline, and at different timepoints.
Changes in Magnetic Resonance Imagining (MRI) assessments will be compared graphically to changes in neurocognitive function and clinical symptoms. Parallel analysis will be conducted on each of the neurocognitive tests to determine if MRI assessments can identify patients at increased risk for later neurocognitive dysfunction.
Measured: Baseline, 6 weeks post radiation therapy (RT), 4 months post RT (whole brain irradiation only), 6 months post RT, 18 months post RT (partial brain irradiation only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study start26 Aug 2004
- Primary completion3 Jun 2014
- Study completion3 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yue Cao, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988675
- Sponsor's protocol ID
- UMCC 2003.083
- Other IDs
- HUM00040138
- Status last verified
- Jun 2018
- First submitted
- 13 Nov 2013
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier
- ClinicalTrials.gov ID
- NCT01988675
- Acronym / sponsor ID
- UMCC 2003.083
- Conditions
- Brain Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 26 Aug 2004 (actual)
- Primary completion
- 3 Jun 2014 (actual)
- Study completion
- 3 Jun 2014 (actual)
- First posted
- 20 Nov 2013 (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.
This is a study to determine if Magnetic Resonance Imaging (MRI) techniques can detect early changes in white matter (in the brain) and the blood-brain barrier resulting from radiation therapy.
Detailed description
Patients will be assigned to one of two groups based on the type of radiation they will be receiving: whole brain irradiation or partial brain irradiation. Patients will undergo Magnetic Resonance Imaging (MRI) assessments, neurocognitive testing (Quality of Life and Neuropsychological assessments), and clinical evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Brain Irradiation | – | Radiation: Partial Brain Irradiation, Behavioral: Neuropsychological Testing, Behavioral: Quality of Life Questionnaire, Device: Magnetic Resonance Imaging (MRI) AssessmentsPatients will receive partial brain irradiation for malignant or benign brain tumors as standard of care. Patients will also have MRI (Magnetic Resonance Imaging) scans and neuropsychological/QOL (Quality of Life Questionnaire) tests prior during and after RT (Radiation Therapy). |
| Whole Brain Irradiation | – | Radiation: Whole Brain Irradiation, Behavioral: Neuropsychological Testing, Behavioral: Quality of Life Questionnaire, Device: Magnetic Resonance Imaging (MRI) AssessmentsPatients will receive whole brain irradiation for brain metastases as standard of care. Patients will also have MRI (Magnetic Resonance Imaging) scans and neuropsychological/QOL (Quality of Life Questionnaire) tests prior during and after RT (Radiation Therapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving partial or whole brain radiation therapy
Key inclusion criteria (5 listed)
- Patients receiving partial brain irradiation for malignant or benign brain tumors (including low-grade gliomas, high-grade gliomas, malignant meningioma, pituitary adenomas, supratentorial meningioma, or craniopharyngiomas); or patients receiving whole brain irradiation for brain metastases.
- Patients must be 18 years of age or older
- Patients must sign a study specific consent form approved by the Institutional Review Board (IRB) of the University of Michigan prior to study entry.
- Patients must have a neurological function class 1 or 2 with a Karnofsky performance status (a scoring system used to quantify general well being and quality of life on a scale of 100 to 0) of greater than or equal to 70.
- Patients must have an expected life expectancy of greater than 6 months.
Key exclusion criteria (5 listed)
- Patients with a history of major medical illness or psychiatric impairment which, in the investigator's opinion, will prevent administration of the protocol.
- Patients who have had prior external beam irradiation to the brain or head/neck area that will lead to overlap of the radiation field.
- Patients should have no contraindications to having a contrast enhanced Magnetic Resonance Imaging (MRI) scan.
- Prisoners are excluded.
- Pregnant women are excluded.
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 |
|---|---|---|
| Whole Brain Irradiation | Radiation | Whole Brain Irradiation |
| Partial Brain Irradiation | Radiation | Partial Brain Irradiation |
| Neuropsychological Testing | Behavioural | Partial Brain Irradiation, Whole Brain Irradiation |
| Quality of Life Questionnaire | Behavioural | Partial Brain Irradiation, Whole Brain Irradiation |
| Magnetic Resonance Imaging (MRI) AssessmentsMRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images). | Device | Partial Brain Irradiation, Whole Brain Irradiation |
Primary outcome
Change in Magnetic Resonance Imagining (MRI) with different radiation dose at different timepoints.
Time frame: Baseline, at 3 weeks on radiation therapy (RT) (partial brain irradiation only), last week of RT, 6 weeks post RT, 4 months post RT (whole brain irradiation only), 6 months post RT, 18 months post RT (partial brain irradiation only)
Linear mixed models will be used to relate Magnetic Resonance Imagining (MRI) changes and radiation dose.
1 secondary outcome
Associate changes in Magnetic Resonance Imagining (MRI) assessments with changes in neurocognitive function and clinical symptoms, from baseline, and at different timepoints.
Time frame: Baseline, 6 weeks post radiation therapy (RT), 4 months post RT (whole brain irradiation only), 6 months post RT, 18 months post RT (partial brain irradiation only)
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 6 Jun 2018.
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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.
Yue Cao, Ph.D. principal investigator
University of Michigan
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 Brain Neoplasms, run by University of Michigan Rogel Cancer Center 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 5 inclusion and 5 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 6 Jun 2018. 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?
Change in Magnetic Resonance Imagining (MRI) with different radiation dose at different timepoints. (time frame: Baseline, at 3 weeks on radiation therapy (RT) (partial brain irradiation only), last week of RT, 6 weeks post RT, 4 months post RT (whole brain irradiation only), 6 months post RT, 18 months post RT (partial brain irradiation only)). 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 6 Jun 2018.