Brain TumorsGliomaNCT01538264
Blood Flow MRI for Monitoring Brain Tumors
An observational study of Brain Tumors, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The investigators are studying the use of an advanced magnetic resonance imaging (MRI) technique for measuring blood flow into brain tumors. This technique does not use radioactive tracers, and it can provide high quality images that can be obtained in a standard MRI scanner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumors
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to 31 Dec 2025
- 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: All subjects will be brain tumor patients recruited through the Brain Tumor Center at the Beth Israel Deaconess Medical Center.
Who may be able to join
- diagnosed with or are suspected of having a glioma
Who cannot join
- contraindications to MRI which may include the following
- Pacemaker
- MRI incompatible metal implant
- Recently implanted vascular clip
- History of claustrophobia
- Metal fragment within the eye
- Subjects who have received nonstandard therapy may be excluded if the therapy might alter tumor blood flow or other imaging characteristic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Blood Flow MRI for Monitoring of Glioma Angiogenesis
The investigators are studying the use of an advanced magnetic resonance imaging (MRI) technique for measuring blood flow into brain tumors. This technique does not use radioactive tracers, and it can provide high quality images that can be obtained in a standard MRI scanner.
Read the detailed description
Our goals are:
- To compare the blood flow measured with this technique with measures of tumor blood vessel density in pieces of the tumor surgically removed as a normal part of clinical treatment. This will confirm a relationship between the imaging measurements and the microscopic characteristics of tumors.
- To compare the blood flow in tumors before therapy with the concentration of choline, an indicator of cell proliferation. This choline concentration can be measured with another MRI technique. This information will demonstrate the relationship between cell proliferation and blood supply and will also determine whether the choline measurement adds additional information that is clinically necessary.
- To determine the reproducibility of blood flow measurements in tumors. This is necessary to better understand the sensitivity of the technique to changes in flow caused by a treatment or changes in tumor vascularity.
- To monitor changes in blood flow after initial treatment. Since sometimes tumors can reappear, the repeated measures will help determine how useful this new imaging technique is at detecting such recurring tumors.
- Conditions
- Brain Tumors
- 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 posted24 Feb 2012 (estimated)
- Study startJun 2006
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, David Alsop, Beth Israel Deaconess Medical Center
- Investigators
- David C Alsop, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538264
- Sponsor's protocol ID
- 2006P000116
- Other IDs
- R01CA115745-05
- Acronym
- Glioma
- Status last verified
- Apr 2024
- First submitted
- 20 Feb 2012
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow MRI for Monitoring of Glioma Angiogenesis
- ClinicalTrials.gov ID
- NCT01538264
- Acronym / sponsor ID
- Glioma / 2006P000116
- Conditions
- Brain Tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2006
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Feb 2012 (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.
The investigators are studying the use of an advanced magnetic resonance imaging (MRI) technique for measuring blood flow into brain tumors. This technique does not use radioactive tracers, and it can provide high quality images that can be obtained in a standard MRI scanner.
Detailed description
Our goals are:
- To compare the blood flow measured with this technique with measures of tumor blood vessel density in pieces of the tumor surgically removed as a normal part of clinical treatment. This will confirm a relationship between the imaging measurements and the microscopic characteristics of tumors.
- To compare the blood flow in tumors before therapy with the concentration of choline, an indicator of cell proliferation. This choline concentration can be measured with another MRI technique. This information will demonstrate the relationship between cell proliferation and blood supply and will also determine whether the choline measurement adds additional information that is clinically necessary.
- To determine the reproducibility of blood flow measurements in tumors. This is necessary to better understand the sensitivity of the technique to changes in flow caused by a treatment or changes in tumor vascularity.
- To monitor changes in blood flow after initial treatment. Since sometimes tumors can reappear, the repeated measures will help determine how useful this new imaging technique is at detecting such recurring tumors.
Study design
- Observational model
- Case only
- 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
- All subjects will be brain tumor patients recruited through the Brain Tumor Center at the Beth Israel Deaconess Medical Center.
Key inclusion criteria (1 listed)
- diagnosed with or are suspected of having a glioma
Key exclusion criteria (7 listed)
- contraindications to MRI which may include the following
- Subjects who have received nonstandard therapy may be excluded if the therapy might alter tumor blood flow or other imaging characteristic.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- 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.
David C Alsop, PhD principal investigator
Beth Israel Deaconess Medical 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 Brain Tumors, run by Beth Israel Deaconess 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 1 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. 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?
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 26 Apr 2024.