Brain MetastasesPhase 1NCT02311556
Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
A Phase 1 study testing dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging in people with Brain Metastases, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2013to 16 Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Assessment of Early Treatment 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.
- Conditions
- Brain Metastases
- Being tested
- dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imagingDevice
Also called DSC-PMR
| Study group | Role | What they receive |
|---|---|---|
| DSC-PMR | Experimental | DSC-PMR (dynamic susceptibility-weighted contrast- enhanced perfusion magnetic resonance imaging) at baseline (screening or time of radiosurgery) and after radiosurgery Receives: Device: dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of radiosurgery and after radiosurgery (approximately 1 week)
Secondary outcomes (4)
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.
Measured: Up to 1 year
Complete response
Complete response = no residue enhancing lesion on MRI
Measured: Up to 1 year
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.
Measured: Up to 1 year
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
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study start7 May 2013
- Primary completion1 Jul 2016
- Study completion16 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiayi Huang, M.D., Principal investigator, Washington University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311556
- Sponsor's protocol ID
- 201302018
- Status last verified
- Feb 2017
- First submitted
- 4 Dec 2014
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Early Treatment Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02311556
- Acronym / sponsor ID
- 201302018
- Conditions
- Brain Metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 7 May 2013 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 16 Dec 2016 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSC-PMR | Experimental | Device: dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imagingDSC-PMR (dynamic susceptibility-weighted contrast- enhanced perfusion magnetic resonance imaging) at baseline (screening or time of radiosurgery) and after radiosurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imagingAlso: DSC-PMR | Device | DSC-PMR |
Primary outcome
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.
4 secondary outcomes
Radiation necrosis
Time frame: Up to 1 year
Complete response
Time frame: Up to 1 year
Elsewhere brain failure
Time frame: Up to 1 year
Clinical deterioration
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiayi Huang, M.D. principal investigator
Washington University of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging in people with Brain Metastases, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to local progression of each treated and evaluable brain metastasis (time frame: At time of radiosurgery and after radiosurgery (approximately 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.