3T MRI Biomarkers of Glioma Treatment Response

Adult Glioblastoma Clinical Trial

Official title:

Early Detection of Glioma Treatment Response Using MRI-Based Biomarkers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01996527
• Other study ID #: VICC NEU 1268
• Secondary ID: NCI-2013-02195P3
• Status: Terminated
• Phase: Early Phase 1
• First received: November 15, 2013
• Last updated: April 13, 2017
• Start date: May 2012
• Est. completion date: January 1, 2016

Study information

• Verified date: April 2017
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 1, 2016
• Est. primary completion date: November 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Anaplastic Astrocytoma
• Adult Anaplastic Ependymoma
• Adult Anaplastic Oligodendroglioma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Astrocytoma
• Ependymoma
• Glioblastoma
• Gliosarcoma
• Oligodendroglioma
• Recurrent Adult Brain Tumor

Intervention

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
• CEST-MRI
Undergo CEST-MRI
• DW-MRI
Undergo DWI-MRI
• DCE-MRI
Undergo DCE-MRI
• 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

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in quantitative MRI-based biomarkers sensitive to tumor protein content	Evaluation of the following biological imaging metrics: 1. Amide proton transfer asymmetry (APTasym, %) from CEST	Baseline to within 4 weeks after on-treatment date
Other	Changes in quantitative MRI-based biomarkers sensitive to tumor cellularity and vascularity	Evaluation of the following biological imaging metrics: Apparent diffusion coefficient (ADC, mm2/s) from DW-MRI; Tissue diffusion coefficient (Dt, mm2/s) from DW-MRI; Pseudo-diffusion coefficient (Dp, mm2/s) from DW-MRI	Baseline to within 4 weeks after on-treatment date
Other	Changes in quantitative MRI-based biomarkers sensitive to tumor perfusion and hemodynamics	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
Other	Changes in quantitative MRI-based biomarkers sensitive to tumor perfusion and hemodynamics	Evaluation of the following biological imaging metrics: Perfusion fraction (fp, %) from DW-MRI; Extravascular extracellular volume fraction (ve, %) from DCE-MRI; Plasma volume fraction (vp, %) from DCE-MRI; Cerebral blood volume (CBV, %) from DSC-MRI	Baseline to within 4 weeks after on-treatment date
Other	Changes in quantitative MRI-based biomarkers sensitive to tumor perfusion and hemodynamics	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
Other	Changes in quantitative MRI-based biomarkers sensitive to tumor perfusion and hemodynamics	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
Primary	Best Response	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)
Secondary	Progression Free Survival (PFS)	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.	On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial