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Completed

NCT Number: NCT02031237

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

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).

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Magnetic Resonance Imaging (MRI) Assessments

Device

MRI scans will include a routine clinical MRI series.

Primary outcomes

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

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

    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.

  2. 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

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

    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).

Secondary outcomes

  1. Change in Mean K^Trans During and After Radiation Therapy

    Time frame: Pre-treatment and 1 Month Post Treatment

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2014
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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