N/A
N=52
MRI Study of Changes in Blood-Brain/Tumor-Barrier Permeability in Patients With Brain Metastases During and After Radiotherapy
Brain Metastases
Bottom Line
View on ClinicalTrials.gov: NCT02031237 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Percentage of the Gross Tumor Volume With a BTB Opening of Ktrans > 0.005 Min-1 — 78.6; 85.6; 6.4; 74.4 percentage of gross tumor volume
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Single Fraction Stereotactic Radiosurgery (SRS) (Radiation); Fractionated Whole Brain Radiation Therapy (WBRT) (Radiation); Fractionated Stereotactic Radiation Therapy (FSRT) (Radiation); Magnetic Resonance Imaging (MRI) Assessments (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of the Gross Tumor Volume With a BTB Opening of Ktrans > 0.005 Min-1 |
78.6; 85.6; 6.4; 74.4; 81.3; 30.2 | — |
| PRIMARY Change in Magnitude and Regional Variability of Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB) Permeability (Per Minute) in Tumor, Tumor Margin, Normal Brain and Brain Metastases |
— | — |
| SECONDARY Change in Mean K^Trans During and After Radiation Therapy |
— | — |
Summary
This study aims to assess changes in vascular permeability in the brain tumor, and in the surrounding brain, due to radiation therapy, using Magnetic Resonance Imaging (MRI).
Eligibility Criteria
Inclusion Criteria
- Patients with a histological confirmed malignancy and presence of intraparenchymal brain metastases
- Patients are treated by WBRT, SRS, or FSRT
- Age greater than or equal to 18 years
- A life expectancy of greater than or equal to 8 weeks
- Karnofsky performance status (an assessment of general well being and ability to do activities of daily living; scale ranges from 0 to 100 where 100 is perfect health) greater than or equal to 60
- Informed consent with signed study-specific informed consent form
Exclusion Criteria
- Major medical or psychiatric illness, which, in the investigator's opinion, will prevent completion of the protocol
- Patients with lepto-meningeal metastases documented by Magnetic Resonance Imagine (MRI), Computed Tomography (CT), or Cerebrospinal Fluid (CSF) evaluation
- For patients that will undergo Whole Brain Radiation Therapy (WBRT), previous WBRT is not allowed. Patients who have had brain metastases managed by Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT), or surgery are eligible
- For patients that will undergo Stereotactic Radiosurgery (SRS), previous Whole Brain Radiation Therapy (WBRT) within 5 months prior to study entry is not allowed. Prior Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT), or surgery is allowed if current treatment will be for a lesion(s) not previously treated.
- For patients that will undergo Fractionated Stereotactic Radiation Therapy (FSRT), previous Whole Brain Radiation Therapy (WBRT) within 5 months prior to study entry is not allowed. Prior Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT), or surgery is allowed if current treatment will be for a lesion(s) not previously treated.
- Patients unable to undergo or tolerate MRI scans (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, etc).
- Patients should have no contraindications to having a contrast enhanced Magnetic Resonance Imaging (MRI) scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the University of Michigan.
- Women who are pregnant are excluded.
Data sourced from ClinicalTrials.gov (NCT02031237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.