Brain MetastasesNCT00602992
Exploring the Role of 3T MRI in Gamma Knife Radiosurgery
An observational study of Brain Metastases, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Gamma Knife radiosurgery is a non-invasive technique for the delivery of a single, high dose of radiation to an intra-cranial target. MRI has an established and central role in the treatment planning process and assessment of response to intracranial radiosurgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2006to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have consented to Gamma Knife radiosurgery.
Who may be able to join
- Patients planned to receive Gamma Knife radiosurgery will be eligible for enrollment on this study.
Who cannot join
- Age<18
- Contra-indications to 3T MRI, such as implanted metal devices or shrapnel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Role of 3T MRI in Gamma Knife Radiosurgery: A Pilot Study
Gamma Knife radiosurgery is a non-invasive technique for the delivery of a single, high dose of radiation to an intra-cranial target. MRI has an established and central role in the treatment planning process and assessment of response to intracranial radiosurgery. Increasing the field strength of MRI from 1.5T to 3T promises to improve the signal, and in turn the quality of images. However, the technology also introduces new limitations, and the role and safety of 3T MRI in the management of patients receiving radiosurgery has not yet been reported. In this pilot study, we will explore the spatial integrity, and incremental image-guidance utility of 3T MRI in patients receiving radiosurgery. The preliminary data acquired in this study will be instrumental to the judicious design and conduct of subsequent definitive clinical trials. Up to fifty patients will be enrolled in this study.
- Conditions
- Brain Metastases
- Keywords
- 3T MRI, Gamma Knife Radiosurgery
- Medical subject headings
- Brain Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startAug 2006
- Primary completionDec 2008
- Study completionDec 2008
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 University Health Network, TorontoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Menard, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602992
- Sponsor's protocol ID
- 06-0427-CE
- Status last verified
- Jun 2016
- First submitted
- 19 Sep 2007
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of 3T MRI in Gamma Knife Radiosurgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT00602992
- Acronym / sponsor ID
- 06-0427-CE
- Conditions
- Brain Metastases
- Keywords
- 3T MRI, Gamma Knife Radiosurgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Jan 2008 (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.
Gamma Knife radiosurgery is a non-invasive technique for the delivery of a single, high dose of radiation to an intra-cranial target. MRI has an established and central role in the treatment planning process and assessment of response to intracranial radiosurgery. Increasing the field strength of MRI from 1.5T to 3T promises to improve the signal, and in turn the quality of images. However, the technology also introduces new limitations, and the role and safety of 3T MRI in the management of patients receiving radiosurgery has not yet been reported. In this pilot study, we will explore the spatial integrity, and incremental image-guidance utility of 3T MRI in patients receiving radiosurgery. The preliminary data acquired in this study will be instrumental to the judicious design and conduct of subsequent definitive clinical trials. Up to fifty patients will be enrolled in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have consented to Gamma Knife radiosurgery.
Key inclusion criteria (1 listed)
- Patients planned to receive Gamma Knife radiosurgery will be eligible for enrollment on this study.
Key exclusion criteria (2 listed)
- Age<18
- Contra-indications to 3T MRI, such as implanted metal devices or shrapnel.
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
Not reported in the source record.
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 23 Jun 2016.
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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.
Cynthia Menard, MD principal investigator
University Health Network, Toronto
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 Brain Metastases, run by University Health Network, Toronto at 1 site in Canada.
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 1 inclusion and 2 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 23 Jun 2016. 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 Canada. 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?
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.
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 23 Jun 2016.