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3T MRI Biomarkers of Glioma Treatment Response

Study Purpose

This pilot clinical trial studies advanced magnetic resonance imaging (MRI) techniques in measuring treatment response in patients with high-grade glioma. New diagnostic procedures, such as advanced MRI techniques at 3 Tesla, may be more effective than standard MRI in measuring treatment response in patients receiving treatment for high-grade gliomas.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01996527
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Vanderbilt-Ingram Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Chad Quarles
Principal Investigator Affiliation Vanderbilt-Ingram Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Device: - 3-Tesla magnetic resonance imaging

3-Tesla MRI is a multiparametric imaging exam that includes MR pulse sequences for CEST-MRI, DW-MRI, DCE-MRI, and DSC-MRI

Device: - CEST-MRI

Undergo CEST-MRI

Device: - DW-MRI

Undergo DWI-MRI

Device: - DCE-MRI

Undergo DCE-MRI

Device: - DSC-MRI

Undergo DSC-MRI

Drug: - IV administration of gadolinium-containing contrast agent

Gadolinium-containing paramagnetic contrast agent (Magnevist®; Berlex Lab, Wayne, New Jersey) in delivered via intravenous (IV) infusion to achieve DCE and DSC contrast

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee

Status

Address

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232