Clinical trial NCT01996527: 3T MRI Biomarkers of Glioma Treatment Response
Official title: Early Detection of Glioma Treatment Response Using MRI-Based Biomarkers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Adult Anaplastic Oligodendroglioma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-11-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 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

Primary outcomes:
measure: Best Response
timeFrame: On-treatment date to date of disease progression (up to 12 weeks)
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)
Other outcomes:
measure: Changes in quantitative MRI-based biomarkers sensitive to tumor protein content
timeFrame: Baseline to within 4 weeks after on-treatment date
measure: Changes in quantitative MRI-based biomarkers sensitive to tumor cellularity and vascularity
timeFrame: Baseline to within 4 weeks after on-treatment date
measure: Changes in quantitative MRI-based biomarkers sensitive to tumor perfusion and hemodynamics
timeFrame: Baseline to within 4 weeks after on-treatment date
measure: Changes in quantitative MRI-based biomarkers sensitive to tumor perfusion and hemodynamics
timeFrame: Baseline to within 4 weeks after on-treatment date
measure: Changes in quantitative MRI-based biomarkers sensitive to tumor perfusion and hemodynamics
timeFrame: Baseline to within 4 weeks after on-treatment date
measure: Changes in quantitative MRI-based biomarkers sensitive to tumor perfusion and hemodynamics
timeFrame: Baseline to within 4 weeks after on-treatment date
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Chad Quarles
role: PRINCIPAL_INVESTIGATOR
References: