3T MRI Biomarkers of Glioma Treatment Response

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Vanderbilt-Ingram Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Chad Quarles, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01996527
First received: November 15, 2013
Last updated: February 4, 2014
Last verified: February 2014
  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.


Condition Intervention
Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Adult Anaplastic Oligodendroglioma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Device: 3-Tesla magnetic resonance imaging
Device: CEST-MRI
Device: DW-MRI
Device: DCE-MRI
Device: DSC-MRI
Drug: IV administration of gadolinium-containing contrast agent

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Detection of Glioma Treatment Response Using MRI-Based Biomarkers

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Best Response [ Time Frame: On‐treatment date to date of disease progression (up to 12 weeks) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Changes in quantitative MRI-based biomarkers sensitive to tumor protein content, tumor perfusion and hemodynamics [ Time Frame: Baseline to within 4 weeks after on-treatment date ] [ Designated as safety issue: No ]

    Evaluation of the following biological imaging metrics:

    1. Amide proton transfer asymmetry (APTasym) from CEST
    2. Apparent diffusion coefficient (ADC) from DW-MRI
    3. Volume transfer constant (Ktrans), extravascular extracellular volume fraction (ve), and plasma volume fraction (vp) from DCE-MRI
    4. Cerebral blood volume (CBV), cerebral blood flow (CBF) and mean transit time (MTT) from DSC-MRI Both conventional anatomic MRI and quantitative MRI sequences will be used in a single "hybrid" imaging exam to be conducted pre-treatment, early after treatment, and at a follow-up time point long

  • Changes in quantitative MRI-based biomarkers using 3.0 Tesla (3T) biomarkers [ Time Frame: Baseline to within 4 weeks after on-treatment date ] [ Designated as safety issue: No ]

    3T MRI techniques, that can supplement existing high-resolution anatomic imaging, will be performed to aid clinical decision-making for patients diagnosed with high-grade glioma. These techniques include:

    1. Chemical Exchange Saturation Transfer (CEST)4
    2. Diffusion Weighted MRI (DWI, or DW-MRI)5,6
    3. Dynamic Contrast Enhanced MRI (DCE-MRI)7
    4. Dynamic Susceptibility Contrast MRI (DSC-MRI)8


Estimated Enrollment: 22
Study Start Date: May 2012
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Other Names:
  • 3-Tesla MRI
  • 3T MRI
Device: CEST-MRI
Undergo CEST-MRI
Other Name: chemical exchange saturation transfer MRI
Device: DW-MRI
Undergo DWI-MRI
Other Name: diffusion-weighted MRI
Device: DCE-MRI
Undergo DCE-MRI
Other Name: dynamic contrast-enhanced MRI
Device: DSC-MRI
Undergo DSC-MRI
Other Name: dynamic susceptibility contrast 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
Other Names:
  • Magnevist®
  • gadopentetate dimeglumine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996527

Contacts
Contact: Vanderbilt-Ingram Clinical Trial Information Program 800-811-8480

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Chad Quarles    615-322-6215    chad.quarles@vanderbilt.edu   
Principal Investigator: Chad Quarles         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Chad Quarles Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Chad Quarles, Assistant Professor of Radiology and Radiological Sciences, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01996527     History of Changes
Other Study ID Numbers: VICC NEU 1268, NCI-2013-02195, P30CA068485
Study First Received: November 15, 2013
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Ependymoma
Gliosarcoma
Oligodendroglioma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Contrast Media
Gadolinium DTPA
Gadobenic acid
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014