Metastatic Brain CancerNCT00610285
A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases
An observational study of Metastatic Brain Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Stereotactic radiosurgery (SRS) is a way to accurately treat brain tumors. SRS involves the use of a special head frame to keep the head from moving during treatment. The head frame makes very accurate treatment possible. The frame must be attached to the skull with special pins. It feels very tight and can hurt. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Brain Cancer
- What is being tested?
- Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jul 2010
- 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: MSKCC Clinic
Who may be able to join
- Histologically confirmed malignancy with the presence of intraparenchymal brain metastases.
- A diagnostic contrast enhanced MRI demonstrating the presence of brain metastases performed within two weeks prior to registration.
- Age ≥ 18 years.
- Must be scheduled or planning to be scheduled for SRS treatment.
- Karnofsky performance status ≥60.
- Patient must sign a study-specific informed consent form. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative.
Who cannot join
- Unable to provide informed consent
- Major medical illness including poor cardiac or pulmonary status which would result in inability of the patient to lie down for the procedure.
- Inability to obtain histologic proof of malignancy.
- Younger than 18 years of age.
- Serum creatinine > 1.3 mg/dl.
- Karnofsky performance status of ≤50.
- Allergy to either CT or MR contrast dyes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Stereotactic radiosurgery (SRS) is a way to accurately treat brain tumors. SRS involves the use of a special head frame to keep the head from moving during treatment. The head frame makes very accurate treatment possible. The frame must be attached to the skull with special pins. It feels very tight and can hurt. A special immobilization device can be used to keep the head from moving.
This device does not need any pins and does not hurt. We would like to see if the new way of holding the head still can be used for SRS. This is the purpose of the study. New X-Ray machines can be used to find if the head has moved in the mask. We hope that we can use these new tools to treat brain tumors just as accurately without using a head frame. It will make treatment more comfortable for the patient. This is why we are asking patients to join the study.
- Conditions
- Metastatic Brain Cancer
- Being tested
- Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)Other
Each patient in the protocol will receive their regularly scheduled SRS treatment plus an additional mock treatment using the non-invasive immobilization system.
| Study group | Role | What they receive |
|---|---|---|
| non-invasive immobilization system | This is a feasibility study to evaluate the accuracy of an alternative, non-invasive immobilization system in combination with image guided patient setup for SRS treatments. The aim is to determine whether or not the non-invasive system can provide comparable accuracy as the conventional invasive head ring system. If successful, patient discomfort can be significantly reduced for such treatments. Receives: Other: Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the setup accuracy of conventional, invasive frame SRS on 10 patients
Measured: conclusion of study
Secondary outcomes (3)
Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the accuracy of an image guided non-invasive (Aktina stereotactic localizer) immobilization system on the same 10 patients as in above.
Measured: conclusion of study
Compare setup accuracy of both systems above, and investigate the feasibility of 'system B' as replacement for 'system A' for single fraction SRS
Measured: conclusion of the study
Compute mean and standard deviation of the intra-fractional motion for non-invasive SRS.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startOct 2005
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Brain CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoshiya Yamada, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610285
- Sponsor's protocol ID
- 05-110
- Status last verified
- Dec 2015
- First submitted
- 14 Jan 2008
- Last updated
- 18 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases
- ClinicalTrials.gov ID
- NCT00610285
- Acronym / sponsor ID
- 05-110
- Conditions
- Metastatic Brain Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Feb 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.
Stereotactic radiosurgery (SRS) is a way to accurately treat brain tumors. SRS involves the use of a special head frame to keep the head from moving during treatment. The head frame makes very accurate treatment possible. The frame must be attached to the skull with special pins. It feels very tight and can hurt. A special immobilization device can be used to keep the head from moving.
This device does not need any pins and does not hurt. We would like to see if the new way of holding the head still can be used for SRS. This is the purpose of the study. New X-Ray machines can be used to find if the head has moved in the mask. We hope that we can use these new tools to treat brain tumors just as accurately without using a head frame. It will make treatment more comfortable for the patient. This is why we are asking patients to join the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-invasive immobilization system | – | Other: Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)This is a feasibility study to evaluate the accuracy of an alternative, non-invasive immobilization system in combination with image guided patient setup for SRS treatments. The aim is to determine whether or not the non-invasive system can provide comparable accuracy as the conventional invasive head ring system. If successful, patient discomfort can be significantly reduced for such treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSKCC Clinic
Key inclusion criteria (6 listed)
- Histologically confirmed malignancy with the presence of intraparenchymal brain metastases.
- A diagnostic contrast enhanced MRI demonstrating the presence of brain metastases performed within two weeks prior to registration.
- Age ≥ 18 years.
- Must be scheduled or planning to be scheduled for SRS treatment.
- Karnofsky performance status ≥60.
Key exclusion criteria (7 listed)
- Unable to provide informed consent
- Major medical illness including poor cardiac or pulmonary status which would result in inability of the patient to lie down for the procedure.
- Inability to obtain histologic proof of malignancy.
- Younger than 18 years of age.
- Serum creatinine > 1.3 mg/dl.
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 |
|---|---|---|
| Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)Each patient in the protocol will receive their regularly scheduled SRS treatment plus an additional mock treatment using the non-invasive immobilization system. | Other | non-invasive immobilization system |
Primary outcome
Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the setup accuracy of conventional, invasive frame SRS on 10 patients
Time frame: conclusion of study
3 secondary outcomes
Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the accuracy of an image guided non-invasive (Aktina stereotactic localizer) immobilization system on the same 10 patients as in above.
Time frame: conclusion of study
Compare setup accuracy of both systems above, and investigate the feasibility of 'system B' as replacement for 'system A' for single fraction SRS
Time frame: conclusion of the study
Compute mean and standard deviation of the intra-fractional motion for non-invasive SRS.
Time frame: conclusion of the study
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 18 Dec 2015.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Yoshiya Yamada, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Cancer, run by Memorial Sloan Kettering Cancer 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 6 inclusion and 7 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 18 Dec 2015. 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?
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?
Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the setup accuracy of conventional, invasive frame SRS on 10 patients (time frame: conclusion of study). 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 18 Dec 2015.