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Completed

NCT Number: NCT02311556

Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging

This study is designed to evaluate whether advanced magnetic resonance imaging (MRI) techniques such as dynamic susceptibility-weighted contrast-enhanced perfusion MRI may be used to predict treatment response of brain metastasis after radiosurgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient must have newly diagnosed brain metastases visible on brain MRI. A biopsy of the lesion is not required as long as the patient has a biopsy-proven malignancy elsewhere and a clinician deems the lesion to be metastatic.
  • At least one brain metastasis must be ≥ 1cm to allow adequate quantitative imaging measurement for DSC-PMR.
  • Patient must be clinically eligible for and elect to be treated with GK alone without WBRT.
  • Patient must be ≥ 18 years of age.
  • Patient must have Karnofsky Performance Status (KPS) of at least 60
  • Patient may be part of other clinical trials (as long as no other local treatments beyond GK such as WBRT or other local therapy are indicated to the brain) or imaging studies.
  • Patient or legally authorized representative must be able to understand and willing to sign a written informed consent document.

Exclusion criteria

  • Patient must not have any medical contraindications to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).
  • Patient must not be pregnant or breastfeeding.
  • Patient must not have an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2.
  • Patient must not have melanoma.
  • Patient must not have hemorrhagic lesions.

Treatment and study plan

dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging

Device

Other names: DSC-PMR

Primary outcomes

  1. Time to local progression of each treated and evaluable brain metastasis

    Time frame: At time of radiosurgery and after radiosurgery (approximately 1 week)

    Tumor perfusion on DSC-PMR will be used as predictor for time to local tumor progression.

Secondary outcomes

  1. Radiation necrosis

    Time frame: Up to 1 year

    Radiation necrosis will be defined by pathology, when available. When no pathology is available, clinical diagnosis based on clinical course and management will be used.

  2. Complete response

    Time frame: Up to 1 year

    Complete response = no residue enhancing lesion on MRI

  3. Elsewhere brain failure

    Time frame: Up to 1 year

    Elsewhere brain failure = appearance of brain metastases outside of the prior radiosurgery region which can be diagnosed radiographically and does not required require pathological confirmation.

  4. Clinical deterioration

    Time frame: Up to 1 year

    Clinical deterioration will be assessed based on the Karnofsky Performance scale (KPS).

    • 100=Normal no complaints; no evidence of disease.
    • 90=Able to carry on normal activity; minor signs or symptoms of disease.
    • 80=Normal activity with effort; some signs or symptoms of disease.
    • 70=Cares for self; unable to carry on normal activity or to do active work.
    • 60=Requires occasional assistance, but is able to care for most of his personal needs.
    • 50=Requires considerable assistance and frequent medical care.
    • 40=Disabled; requires special care and assistance.
    • 30=Severely disabled; hospital admission is indicated although death not imminent.
    • 20=Very sick; hospital admission necessary; active supportive treatment necessary.
    • 10=Moribund; fatal processes progressing rapidly.
    • 0=Dead

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Assessment of Early Treatment Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 8, 2014
Registry last updated
Feb 24, 2017

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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