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

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Brain Metastases

Treatments: Radiation: Fractionated Whole Brain Radiation Therapy (WBRT); Radiation: Single Fraction Stereotactic Radiosurgery (SRS); Device: Magnetic Resonance Imaging (MRI) Assessments; Radiation: Fractionated Stereotactic Radiation Therapy (FSRT)

Study type: Observational

Funder types: Other

Identifiers

NCT02031237

HUM00043426 (Other Identifier)

UMCC 2005.003

Details and patient eligibility

About

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).

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

52 participants in 3 patient groups

Stereotactic Radiosurgery (SRS)

Description:

Patients with brain metastases receiving single fraction Stereotactic Radiosurgery (SRS). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to SRS, and 1-2 weeks and 1 month after SRS. The MRI scan will include a routine clinical MRI series.

Treatment:

Radiation: Single Fraction Stereotactic Radiosurgery (SRS)

Device: Magnetic Resonance Imaging (MRI) Assessments

Whole Brain Radiation Therapy

Description:

Patients with brain metastases receiving fractionated (spread out over time) Whole Brain Radiation Therapy (WBRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to RT, at the end of RT and 1 month after RT. The MRI scan will include a routine clinical MRI series.

Treatment:

Device: Magnetic Resonance Imaging (MRI) Assessments

Radiation: Fractionated Whole Brain Radiation Therapy (WBRT)

Stereotactic Radiation Therapy

Description:

Patients with brain metastases receiving fractionated (spread out over time) Stereotactic Radiation Therapy (FSRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to FSRT, during the last week of RT but before the last fraction and 1 month after RT. The MRI scan will include a routine clinical MRI series.

Treatment:

Device: Magnetic Resonance Imaging (MRI) Assessments

Radiation: Fractionated Stereotactic Radiation Therapy (FSRT)