Brain TumorNCT02006563
Metabolic Tumor Volumes in Radiation Treatment of Primary Brain Tumors
An observational study of Brain Tumor and Glioblastoma Multiforme, run by University of Miami at 1 site in United States.
Trial summary
Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Glioblastoma Multiforme
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2011to Jul 2017
- 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: It is estimated that approximately 39% of the patients with primary brain tumors, seen in the Department of Radiation Oncology, Sylvester Cancer Center are women. Further, it is estimated that 58% of patients are White, 6% are African American, 36% are Hispanic and 0% are other based upon standard NIH definitions.
Who may be able to join
- Patients must have histologically confirmed primary brain tumor.
- Patients may be enrolled prior to surgery, after surgical resection or with unresectable tumors.
- Patients must be 18 years or older.
- Patients who do not have metal in the body (e.g. pacemakers, implants) that would preclude them from undergoing MRI/MRS exam
- Patients who do not suffer from claustrophobia (fear of enclosed spaces)
- Karnofsky performance status ≥ 60.
- Patients whose size would allow them to fit into the bore of the MRI instrument.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients younger than 18 years.
- Inability to undergo MRI/MRS exam because of metal in the head or body, such as implants, pacemaker, or biostimulation device. Claustrophobia (fear of enclosed spaces).
- Karnofsky performance status < 60.
- Patients too large (> 300 lbs.) to fit into the bore of the MRI instrument.
- Inability to understand the informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Metabolic Tumor Volumes in Radiation of Primary Brain Tumors
- Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors.
- If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV.
- Alternatively, if CTV > MTV, then the difference in volumes is related to higher treatment toxicity.
Read the detailed description
Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors.
- If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV.
- Alternatively, if CTV > MTV, then the difference in volumes is related to higher treatment toxicity.
- Conditions
- Brain Tumor, Glioblastoma Multiforme
- Keywords
- Brain Tumor, Glioblastoma multiforme, GBM, Metabolic Tumor Volume, MTV, Clinical Tumor Volume, CTV
- Medical subject headings
- Brain Neoplasms, Glioblastoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between Metabolic Tumor Volumes and Clinical Tumor Volumes in Patients with Brain Tumors
To evaluate the extent to which tumor volumes, determined by spectroscopic imaging (MTV) differ from the traditionally prescribed clinical treatment volumes (CTV) for radiation therapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study start8 Jun 2011
- Primary completionJan 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radka S. Stoyanova, University of Miami
- Investigators
- Radka Stoyanova, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006563
- Sponsor's protocol ID
- 20100809
- Status last verified
- Oct 2017
- First submitted
- 4 Dec 2013
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metabolic Tumor Volumes in Radiation of Primary Brain Tumors
- ClinicalTrials.gov ID
- NCT02006563
- Acronym / sponsor ID
- 20100809
- Conditions
- Brain Tumor, Glioblastoma Multiforme
- Keywords
- Brain Tumor, Glioblastoma multiforme, GBM, Metabolic Tumor Volume, MTV, Clinical Tumor Volume, CTV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 8 Jun 2011 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 10 Dec 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.
- Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors.
- If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV.
- Alternatively, if CTV > MTV, then the difference in volumes is related to higher treatment toxicity.
Detailed description
Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors.
- If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV.
- Alternatively, if CTV > MTV, then the difference in volumes is related to higher treatment toxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is estimated that approximately 39% of the patients with primary brain tumors, seen in the Department of Radiation Oncology, Sylvester Cancer Center are women. Further, it is estimated that 58% of patients are White, 6% are African American, 36% are Hispanic and 0% are other based upon standard NIH definitions.
Key inclusion criteria (8 listed)
- Patients must have histologically confirmed primary brain tumor.
- Patients may be enrolled prior to surgery, after surgical resection or with unresectable tumors.
- Patients must be 18 years or older.
- Patients who do not have metal in the body (e.g. pacemakers, implants) that would preclude them from undergoing MRI/MRS exam
- Patients who do not suffer from claustrophobia (fear of enclosed spaces)
Key exclusion criteria (5 listed)
- Patients younger than 18 years.
- Inability to undergo MRI/MRS exam because of metal in the head or body, such as implants, pacemaker, or biostimulation device. Claustrophobia (fear of enclosed spaces).
- Karnofsky performance status < 60.
- Patients too large (> 300 lbs.) to fit into the bore of the MRI instrument.
- Inability to understand the informed consent document.
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
Difference between Metabolic Tumor Volumes and Clinical Tumor Volumes in Patients with Brain Tumors
Time frame: 2 years
To evaluate the extent to which tumor volumes, determined by spectroscopic imaging (MTV) differ from the traditionally prescribed clinical treatment volumes (CTV) for radiation therapy
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 Oct 2017.
- 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.
Radka Stoyanova, PhD principal investigator
University of Miami
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 Tumor and Glioblastoma Multiforme, run by University of Miami 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 8 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 Oct 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.
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?
Difference between Metabolic Tumor Volumes and Clinical Tumor Volumes in Patients with Brain Tumors (time frame: 2 years). 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 Oct 2017.