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3T MRI Biomarkers of Glioma Treatment Response

Primary Purpose

Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

3-Tesla magnetic resonance imaging

CEST-MRI

DW-MRI

DCE-MRI

DSC-MRI

IV administration of gadolinium-containing contrast agent

About this trial

This is an interventional diagnostic trial for Adult Anaplastic Astrocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3-Tesla magnetic resonance imaging

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01996527

First Posted

November 15, 2013

Last Updated

April 13, 2017

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01996527

Brief Title

3T MRI Biomarkers of Glioma Treatment Response

Official Title

Early Detection of Glioma Treatment Response Using MRI-Based Biomarkers

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Terminated

Why Stopped

PI left institution

Study Start Date

May 2012 (undefined)

Primary Completion Date

November 23, 2015 (Actual)

Study Completion Date

January 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3-Tesla magnetic resonance imaging

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

3-Tesla magnetic resonance imaging

Other Intervention Name(s)

3-Tesla MRI, 3T MRI

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

CEST-MRI

Other Intervention Name(s)

chemical exchange saturation transfer MRI

Intervention Description

Undergo CEST-MRI

Intervention Type

Device

Intervention Name(s)

DW-MRI

Other Intervention Name(s)

diffusion-weighted MRI

Intervention Description

Undergo DWI-MRI

Intervention Type

Device

Intervention Name(s)

DCE-MRI

Other Intervention Name(s)

dynamic contrast-enhanced MRI

Intervention Description

Undergo DCE-MRI

Intervention Type

Device

Intervention Name(s)

DSC-MRI

Other Intervention Name(s)

dynamic susceptibility contrast MRI

Intervention Description

Undergo DSC-MRI

Intervention Type

Drug

Intervention Name(s)

IV administration of gadolinium-containing contrast agent

Other Intervention Name(s)

Magnevist®, gadopentetate dimeglumine

Intervention Description

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

Primary Outcome Measure Information:

Title

Best Response

Description

Time Frame

On-treatment date to date of disease progression (up to 12 weeks)

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)

Other Pre-specified Outcome Measures:

Title

Changes in quantitative MRI-based biomarkers sensitive to tumor protein content

Description

Evaluation of the following biological imaging metrics: 1. Amide proton transfer asymmetry (APTasym, %) from CEST

Time Frame