Metastatic Brain TumorNCT01908179
Markers of Prognosis and Response to Therapy in Patients With Metastatic Brain Tumors Undergoing Stereotactic Radiosurgery (SRS)
An observational study of Metastatic Brain Tumor, run by Swedish Medical Center at 1 site in United States.
Trial summary
This registry study will evaluate patients with metastatic brain tumors undergoing, or having undergone, stereotactic radiosurgery (SRS) at Swedish Medical Center. Clinical outcomes will be evaluated at the 3, 6 and 12-month time points. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Metastatic Brain Tumor
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jul 2015
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic brain tumors undergoing, or have undergone, sterotactic radiosurgery (SRS)
Who may be able to join
- Adult patients (>18 yo) with a pathological diagnosis of metastatic brain cancer
- Participants must have >4 tumors felt to require stereotactic radiosurgery
- Karnofsky scale of > 70 at the time of initial treatment
- Age < 80
Who cannot join
- Karnofsky scale <70
- Age > 80
- Inability to undergo MR imaging studies
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Swedish Medical Center
Seattle, Washington, 98122
Tracie Granger, 206-215-2466, tracie.granger@swedish.org
Sarah Fouke, MD
About this study
This registry study will evaluate patients with metastatic brain tumors undergoing, or having undergone, stereotactic radiosurgery (SRS) at Swedish Medical Center. Clinical outcomes will be evaluated at the 3, 6 and 12-month time points. Clinical data, SRS treatment data, and imaging data (including anatomic and advanced imaging sequences obtained prior to and serially following SRS) will be archived in an online informatics platform, specifically a metastatic brain tumor registry known as the Comprehensive Neuro-oncology Data Repository for Metastatic Tumors (CONDR - Mets).
- Conditions
- Metastatic Brain Tumor
- Keywords
- Sterotactic Radiosurgery
- Medical subject headings
- Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative measures of overall tumor volume will be performed for each subject at the time of SRS
Measured: At the time of SRS
Quantitative measures of tumor number will be performed for each subject at the time of SRS
Measured: At the time of SRS
Overall survival will be measured for each subject (in weeks from SRS to death)
Measured: Post-SRS
Secondary outcomes (3)
Measures of ADC, rCBV, MTT and ktrans will be performed for each treated tumor at treatment and at 6 months following SRS
Measured: 6 months post SRS
Time to progression (in weeks) will be measured for each treated tumor
Measured: Post-SRS
Diagnosis of progression or radiation necrosis (made on clinical reflection at study's end) will be determined for tumors where diagnosis is in question at 6 and 12 months after SRS
Measured: 12 months post-SRS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Brain TumorStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908179
- Sponsor's protocol ID
- SRS - Mets
- Status last verified
- Jul 2013
- First submitted
- 23 Jul 2013
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Prognosis and Response to Therapy in Patients With Metastatic Brain Tumors Undergoing Stereotactic Radiosurgery (SRS)
- ClinicalTrials.gov ID
- NCT01908179
- Acronym / sponsor ID
- SRS - Mets
- Conditions
- Metastatic Brain Tumor
- Keywords
- Sterotactic Radiosurgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (estimated)
- First posted
- 25 Jul 2013 (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 registry study will evaluate patients with metastatic brain tumors undergoing, or having undergone, stereotactic radiosurgery (SRS) at Swedish Medical Center. Clinical outcomes will be evaluated at the 3, 6 and 12-month time points. Clinical data, SRS treatment data, and imaging data (including anatomic and advanced imaging sequences obtained prior to and serially following SRS) will be archived in an online informatics platform, specifically a metastatic brain tumor registry known as the Comprehensive Neuro-oncology Data Repository for Metastatic Tumors (CONDR - Mets).
Study design
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic brain tumors undergoing, or have undergone, sterotactic radiosurgery (SRS)
Key inclusion criteria (4 listed)
- Adult patients (>18 yo) with a pathological diagnosis of metastatic brain cancer
- Participants must have >4 tumors felt to require stereotactic radiosurgery
- Karnofsky scale of > 70 at the time of initial treatment
- Age < 80
Key exclusion criteria (3 listed)
- Karnofsky scale <70
- Age > 80
- Inability to undergo MR imaging studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative measures of overall tumor volume will be performed for each subject at the time of SRS
Time frame: At the time of SRS
Quantitative measures of tumor number will be performed for each subject at the time of SRS
Time frame: At the time of SRS
Overall survival will be measured for each subject (in weeks from SRS to death)
Time frame: Post-SRS
3 secondary outcomes
Measures of ADC, rCBV, MTT and ktrans will be performed for each treated tumor at treatment and at 6 months following SRS
Time frame: 6 months post SRS
Time to progression (in weeks) will be measured for each treated tumor
Time frame: Post-SRS
Diagnosis of progression or radiation necrosis (made on clinical reflection at study's end) will be determined for tumors where diagnosis is in question at 6 and 12 months after SRS
Time frame: 12 months post-SRS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Brain Tumor, run by Swedish Medical Center 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jul 2013. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tracie Granger (206-215-2466, tracie.granger@swedish.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative measures of overall tumor volume will be performed for each subject at the time of SRS (time frame: At the time of SRS). The study lists 3 primary outcomes in all. 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 25 Jul 2013.