MRI Study of Changes in Blood-Brain/Tumor-Barrier Permeability in Patients With Brain Metastases During and After Radiotherapy

N/ACompletedNCT02031237

University of Michigan Rogel Cancer Center52 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Brain Metastases

Interventions

Single Fraction Stereotactic Radiosurgery (SRS)RADIATION

Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.

Fractionated Whole Brain Radiation Therapy (WBRT)RADIATION

Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.

Fractionated Stereotactic Radiation Therapy (FSRT)RADIATION

Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Michigan Hospital

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Percentage of the Gross Tumor Volume With a BTB Opening of Ktrans > 0.005 Min-1

Fifty metastatic lesions from 21 patients received WBRT and 14 lesions from 9 patients treated by SRS were analyzed. Permeability of BTB (Blood-Tumor-Barrier) was quantified by the transfer constant, Ktrans, derived from dynamic contrast enhanced (DCE)-MRI that were acquired pre, 1-2 weeks after starting, and 1-month post-radiotherapy. A percentage volume of the BM with Ktrans \>0.005 min-1 (%Vall) was used to evaluate the extent of BTB opening pre-RT and subsequent changes after receiving radiotherapy. The 50 lesions, from the 21 patients treated with Whole Brain Radiation Therapy, were divided into two subgroups: low-leaky (%Vall \<50%) and high-leaky, based upon pre-RT measurements. Of the 50 lesions, 7 were classified as low leaky and 43 were classified as high leaky. All 14 SRS lesions were classified as high leaky.

Time frame: Pre-Treatment, 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment

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

An in-house program, based on a general kinetic model, along with an MRI contrast agent, Gadopentetic Acid (Gd-DTPA), will be used to estimate vascular permeability (per minute).

Time frame: Week -2 to -1, End of Treatment (WBRT), 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment

Secondary Outcomes

Change in Mean K^Trans During and After Radiation Therapy

Effect of radiation dose on vascular permeability (per minute) of the Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB). Permeability of BTB was quantified by Ktrans.

Time frame: Pre-treatment and 1 Month Post Treatment

Data from ClinicalTrials.gov

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