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

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02311556
• Other study ID #: 201302018
• Status: Completed
• Phase: Phase 1
• First received: December 4, 2014
• Last updated: February 22, 2017
• Start date: May 7, 2013
• Est. completion date: December 16, 2016

Study information

• Verified date: February 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 16, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Disease Susceptibility
• Neoplasm Metastasis

Intervention

Device:
• dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to local progression of each treated and evaluable brain metastasis	Tumor perfusion on DSC-PMR will be used as predictor for time to local tumor progression.	At time of radiosurgery and after radiosurgery (approximately 1 week)
Secondary	Radiation necrosis	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.	Up to 1 year
Secondary	Complete response	Complete response = no residue enhancing lesion on MRI	Up to 1 year
Secondary	Elsewhere brain failure	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.	Up to 1 year
Secondary	Clinical deterioration	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	Up to 1 year

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine