GliomaNCT01263821
Image Guided Therapy in the Treatment of Gliomas
A study testing Diffusion-weighted magnetic resonance imaging, Perfusion-weighted magnetic resonance imaging and Functional magnetic resonance imaging in people with Glioma, run by NYU Langone Health at 1 site in United States.
Trial summary
RATIONALE: New imaging techniques using magnetic resonance imaging give better tumor definition, thus may lead to better tumor targeting and avoid damaging critical parts of normal brain. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Diffusion-weighted magnetic resonance imaging, Perfusion-weighted magnetic resonance imaging and Functional magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Apr 2014
- Phase
- Interventional
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed, newly diagnosed intracranial glioma
- A diagnostic contrast enhanced CT/MRI demonstrating the lesion prior to registration
- Karnofsky performance status >= 60
- Ability to undergo MR imaging with the use of Gadolinium dye
- 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
- Inability to obtain histological proof of glioma
- Allergy to Gadolinium contrast
- Any condition including metallic implants or cardiac pace makers that make the candidate ineligible for MR imaging
- Any medical condition including renal or cardiac insufficiency that make the candidate a high risk for gadolinium contrast administration
- Karnofsky performance status of =< 50
- Prior history of radiation therapy to the brain
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas
RATIONALE: New imaging techniques using magnetic resonance imaging give better tumor definition, thus may lead to better tumor targeting and avoid damaging critical parts of normal brain.
PURPOSE: This phase I/II trial is studying how well image-guided therapy works in treating patients with newly diagnosed intracranial glioma.
Read the detailed description
PRIMARY OBJECTIVES:
- To correlate the imaging findings with pathological grade following surgery in patients with newly diagnosed intra-cranial gliomas.
SECONDARY OBJECTIVES:
- To determine the feasibility of defining the optimal target volume for radiation therapy using MR spectroscopy, diffusion, perfusion and functional imaging. II. To monitor therapeutic responses following treatment using MR spectroscopy, diffusion imaging and perfusion study.
III. To monitor changes in neurocognitive functioning following image guided therapy.
OUTLINE: Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks. After completion of study treatment, patients are followed up every 3 months for the first year then every 6 months for another year.
- Conditions
- Glioma
- Being tested
- Diffusion-weighted magnetic resonance imaging, Perfusion-weighted magnetic resonance imaging, Functional magnetic resonance imaging, Magnetic resonance spectroscopic imaging, Therapeutic conventional surgery
- Keywords
- glioma, biologic imaging, magnetic resonance spectroscopy, magnetic resonance imaging, perfusion imaging, diffusion imaging, functional magnetic resonance imaging, radiation therapy, intensity modulated radiation therapy
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion-weighted magnetic resonance imagingProcedure or surgery
Also called Diffusion-weighted MRI
Undergo diffusion-weighted MRI
Perfusion-weighted magnetic resonance imagingProcedure or surgery
Also called Perfusion-weighted MRI
Undergo perfusion-weighted magnetic resonance imaging
Functional magnetic resonance imagingProcedure or surgery
Also called fMRI, functional MRI
Undergo functional MRI
Magnetic resonance spectroscopic imagingProcedure or surgery
Also called 1H-nuclear MRSI, Proton MRSI
Undergo MR spectroscopic imaging
Therapeutic conventional surgeryProcedure or surgery
Undergo maximal surgical resection
Quality-of-life assessmentProcedure or surgery
Ancillary studies
Radiation therapy treatment planning/simulationProcedure or surgery
Undergo IMRT planning
Intensity-modulated radiation therapyProcedure or surgery
Also called IMRT
Undergo intensity-modulated radiation therapy
Questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks. Receives: Procedure: Diffusion-weighted magnetic resonance imaging; Procedure: Perfusion-weighted magnetic resonance imaging; Procedure: Functional magnetic resonance imaging; Procedure: Magnetic resonance spectroscopic imaging; Procedure: Therapeutic conventional surgery; Procedure: Quality-of-life assessment; Procedure: Radiation therapy treatment planning/simulation; Procedure: Intensity-modulated radiation therapy; Other: Questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of identifying low grade and high grade tumor location with imaging techniques that include MRSI,perfusion MRI, and DTI
Measured: Twice a year, after enrollment of first 25 patients, and at study completion
Secondary outcomes (2)
Incorporate imaging techniques of MRSI, perfusion MRI and DTI into the radiotherapy treatment planning system for target delineation
Measured: Twice a year, after enrollment of first 25 patients, and at study completion
Clinical efficacy of this biological image-guided treatment in gliomas
Measured: Twice a year, after enrollment of first 25 patients, and at study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startAug 2009
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Silverman, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263821
- Sponsor's protocol ID
- 09-0069
- Status last verified
- Aug 2017
- First submitted
- 16 Dec 2010
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas
- ClinicalTrials.gov ID
- NCT01263821
- Acronym / sponsor ID
- 09-0069
- Conditions
- Glioma
- Keywords
- glioma, biologic imaging, magnetic resonance spectroscopy, magnetic resonance imaging, perfusion imaging, diffusion imaging, functional magnetic resonance imaging, radiation therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Dec 2010 (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.
RATIONALE: New imaging techniques using magnetic resonance imaging give better tumor definition, thus may lead to better tumor targeting and avoid damaging critical parts of normal brain.
PURPOSE: This phase I/II trial is studying how well image-guided therapy works in treating patients with newly diagnosed intracranial glioma.
Detailed description
PRIMARY OBJECTIVES:
- To correlate the imaging findings with pathological grade following surgery in patients with newly diagnosed intra-cranial gliomas.
SECONDARY OBJECTIVES:
- To determine the feasibility of defining the optimal target volume for radiation therapy using MR spectroscopy, diffusion, perfusion and functional imaging. II. To monitor therapeutic responses following treatment using MR spectroscopy, diffusion imaging and perfusion study.
III. To monitor changes in neurocognitive functioning following image guided therapy.
OUTLINE: Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks. After completion of study treatment, patients are followed up every 3 months for the first year then every 6 months for another year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: Diffusion-weighted magnetic resonance imaging, Procedure: Perfusion-weighted magnetic resonance imaging, Procedure: Functional magnetic resonance imaging, Procedure: Magnetic resonance spectroscopic imaging, Procedure: Therapeutic conventional surgery, Procedure: Quality-of-life assessment, Procedure: Radiation therapy treatment planning/simulation, Procedure: Intensity-modulated radiation therapy, Other: Questionnaire administrationPatients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed, newly diagnosed intracranial glioma
- A diagnostic contrast enhanced CT/MRI demonstrating the lesion prior to registration
- Karnofsky performance status >= 60
- Ability to undergo MR imaging with the use of Gadolinium dye
- 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
Key exclusion criteria (7 listed)
- Inability to obtain histological proof of glioma
- Allergy to Gadolinium contrast
- Any condition including metallic implants or cardiac pace makers that make the candidate ineligible for MR imaging
- Any medical condition including renal or cardiac insufficiency that make the candidate a high risk for gadolinium contrast administration
- Karnofsky performance status of =< 50
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 |
|---|---|---|
| Diffusion-weighted magnetic resonance imagingAlso: Diffusion-weighted MRIUndergo diffusion-weighted MRI | Procedure or surgery | Arm I |
| Perfusion-weighted magnetic resonance imagingAlso: Perfusion-weighted MRIUndergo perfusion-weighted magnetic resonance imaging | Procedure or surgery | Arm I |
| Functional magnetic resonance imagingAlso: fMRI, functional MRIUndergo functional MRI | Procedure or surgery | Arm I |
| Magnetic resonance spectroscopic imagingAlso: 1H-nuclear MRSI, Proton MRSIUndergo MR spectroscopic imaging | Procedure or surgery | Arm I |
| Therapeutic conventional surgeryUndergo maximal surgical resection | Procedure or surgery | Arm I |
| Quality-of-life assessmentAncillary studies | Procedure or surgery | Arm I |
| Radiation therapy treatment planning/simulationUndergo IMRT planning | Procedure or surgery | Arm I |
| Intensity-modulated radiation therapyAlso: IMRTUndergo intensity-modulated radiation therapy | Procedure or surgery | Arm I |
| Questionnaire administrationAncillary studies | Other | Arm I |
Primary outcome
Feasibility of identifying low grade and high grade tumor location with imaging techniques that include MRSI,perfusion MRI, and DTI
Time frame: Twice a year, after enrollment of first 25 patients, and at study completion
2 secondary outcomes
Incorporate imaging techniques of MRSI, perfusion MRI and DTI into the radiotherapy treatment planning system for target delineation
Time frame: Twice a year, after enrollment of first 25 patients, and at study completion
Clinical efficacy of this biological image-guided treatment in gliomas
Time frame: Twice a year, after enrollment of first 25 patients, and at study completion
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
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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.
Joshua Silverman, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion-weighted magnetic resonance imaging, Perfusion-weighted magnetic resonance imaging and Functional magnetic resonance imaging in people with Glioma, run by NYU Langone Health 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 5 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: stopped early, as of the sponsor's last update on 4 Aug 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 was stopped early (reason given: Lack of enrollment). 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.
What does the primary outcome measure?
Feasibility of identifying low grade and high grade tumor location with imaging techniques that include MRSI,perfusion MRI, and DTI (time frame: Twice a year, after enrollment of first 25 patients, and at study completion). 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 4 Aug 2017.