- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01996527
3T MRI Biomarkers of Glioma Treatment Response
Early Detection of Glioma Treatment Response Using MRI-Based Biomarkers
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To correlate treatment-induced changes in quantitative MRI-based biomarkers-specifically, those sensitive to tumor protein content (amide proton transfer asymmetry [APTasym] from chemical exchange saturation transfer [CEST]), cellularity (apparent diffusion coefficient [ADC] from diffusion-weighted imaging [DWI]), and blood flow (volume transfer constant [K^trans] from dynamic contrast-enhanced [DCE]; cerebral blood flow [CBF] from dynamic susceptibility contrast [DSC])-with treatment-induced changes in tumor size, measured via standard anatomic MRI.
II. To correlate treatment-induced changes in the above quantitative MRI endpoints with patient progression-free survival (PFS).
OUTLINE:
Patients undergo measurement of tumor protein content using CEST-MRI, cellularity using DWI-MRI, and blood flow using DCE-MRI and DSC-MRI within 2 weeks of treatment and at 2 and 4 weeks after initiation of treatment.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt-Ingram Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must sign an institutional review board (IRB)-approved informed consent document
Patients must have been diagnosed with high-grade glioma:
- World Health Organization (WHO) grade III: anaplastic astrocytoma, oligodendroglioma, ependymoma, or oligoastrocytoma; OR
- WHO grade IV: glioblastoma multiforme; or neuroepithelial tumors of uncertain origin (polar spongioblastoma, astroblastoma, or gliomatosis cerebri)
- As measured by conventional high spatial resolution MRI, the minimum diameter of the primary lesion (short axis) should be at least 5 mm
- Patients must be scheduled to receive: 1) standard chemotherapy with/without radiation therapy; OR 2) single-agent bevacizumab (Avastin)
Exclusion Criteria:
- Patients with low-grade (WHO grade I or II) glioma
- Patients with metastatic disease
- Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction
- Patients who have any type of ferromagnetic bioimplant that could potentially be displaced
- Patients who have cerebral aneurysm clips
- Patients who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes)
- Patients with inadequate renal function (creatinine >= 1.5 times upper limit of normal) or acute or chronic renal insufficiency (glomerular filtration rate < 20 ml/min)
- Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
- Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet bore
Patients incapable of giving informed written consent, for the following reasons:
- Inability to adhere to the experimental protocols for any reason
- Inability to communicate with the research team
Limited ability to give informed consent due to mental disability, altered mental status, confusion, cognitive impairment, or psychiatric disorders
- Patients scoring 14.5 or lower on the University of California at San Diego (UCSD) Brief Assessment of Consent Capacity (UBACC) Capacity to Consent Questionnaire will be excluded
- Prisoners or other individuals deemed to be susceptible to coercion
- For patients who have undergone surgical resection prior to joining the study, in whom baseline magnetic resonance (MR) images exhibit enough signal degradation (due to susceptibility artifact in the region of the surgical bed) such that the data are uninterpretable will be excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3-Tesla magnetic resonance imaging
Patients undergo 3-Tesla magnetic resonance imaging to measure tumor protein content (using CEST-MRI), cellularity (using DW-MRI), and blood flow (using DCE-MRI and DSC-MRI with IV administration of gadolinium-containing contrast agent) no more than 2 weeks before, and 2 and 4 weeks after, the initiation of treatment.
|
3-Tesla MRI is a multiparametric imaging exam that includes MR pulse sequences for CEST-MRI, DW-MRI, DCE-MRI, and DSC-MRI
Other Names:
Undergo CEST-MRI
Other Names:
Undergo DWI-MRI
Other Names:
Undergo DCE-MRI
Other Names:
Undergo DSC-MRI
Other Names:
Gadolinium-containing paramagnetic contrast agent (Magnevist®; Berlex Lab, Wayne, New Jersey) in delivered via intravenous (IV) infusion to achieve DCE and DSC contrast
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best Response
Time Frame: On-treatment date to date of disease progression (up to 12 weeks)
|
Number of patients in each response category, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, summarized as follows for target lesion criteria: complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD.
Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.
|
On-treatment date to date of disease progression (up to 12 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS)
Time Frame: On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)
|
Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring.
Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters (LD) of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
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On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in quantitative MRI-based biomarkers sensitive to tumor protein content
Time Frame: Baseline to within 4 weeks after on-treatment date
|
Evaluation of the following biological imaging metrics: 1. Amide proton transfer asymmetry (APTasym, %) from CEST |
Baseline to within 4 weeks after on-treatment date
|
Changes in quantitative MRI-based biomarkers sensitive to tumor cellularity and vascularity
Time Frame: Baseline to within 4 weeks after on-treatment date
|
Evaluation of the following biological imaging metrics:
|
Baseline to within 4 weeks after on-treatment date
|
Changes in quantitative MRI-based biomarkers sensitive to tumor perfusion and hemodynamics
Time Frame: Baseline to within 4 weeks after on-treatment date
|
Evaluation of the following biological imaging metrics: 1. Volume transfer constant (Ktrans, 1/min) from DCE-MRI |
Baseline to within 4 weeks after on-treatment date
|
Changes in quantitative MRI-based biomarkers sensitive to tumor perfusion and hemodynamics
Time Frame: Baseline to within 4 weeks after on-treatment date
|
Evaluation of the following biological imaging metrics:
|
Baseline to within 4 weeks after on-treatment date
|
Changes in quantitative MRI-based biomarkers sensitive to tumor perfusion and hemodynamics
Time Frame: Baseline to within 4 weeks after on-treatment date
|
Evaluation of the following biological imaging metrics: 1. Cerebral blood flow (CBF, ml/min/100 g) from DSC-MRI |
Baseline to within 4 weeks after on-treatment date
|
Changes in quantitative MRI-based biomarkers sensitive to tumor perfusion and hemodynamics
Time Frame: Baseline to within 4 weeks after on-treatment date
|
Evaluation of the following biological imaging metrics: 1. Mean transit time (MTT, s) from DSC-MRI |
Baseline to within 4 weeks after on-treatment date
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chad Quarles, Vanderbilt-Ingram Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC NEU 1268
- P30CA068485 (U.S. NIH Grant/Contract)
- NCI-2013-02195 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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