search
Back to results

Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas

Primary Purpose

Adult Glioblastoma

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
3 Tesla magnetic resonance imaging
Chemical exchange saturation transfer MRI
Diffusion weighted MRI
Dynamic susceptibility contrast MRI
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adult Glioblastoma focused on measuring Glioblastoma, MRI, standard treatment

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must have radiologically and histologically confirmed diagnosis of newly diagnosed glioblastoma
  • Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter
  • Life expectancy of greater than 3 months
  • Patients scheduled for standard therapy (6 weeks radiation treatment (RT) ~ 60 Gy, plus temozolomide 75 mg/m^2 during 6 week RT, and followed routine monthly temozolomide therapy)
  • Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines

Exclusion Criteria:

  • Patients who underwent complete resection
  • Patients with no evidence of measurable disease after surgery
  • Patients who have had chemotherapy or radiotherapy
  • Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction
  • Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
  • 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

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MR imaging and standard treatment

Arm Description

Patients with glioblastoma undergo 3-Tesla magnetic resonance imaging to measure tumor protein content (using CEST-MRI), cellularity (using DW-MRI), and perfusion (using DCE-MRI and DSC-MRI with IV administration of gadolinium-containing contrast agent) at pre-CCRT; 4 weeks after completion of the CCRT; and every 2 or 3 months during the adjuvant temozolomide therapy.

Outcomes

Primary Outcome Measures

Diagnostic Performance of Response Rate
The response was determined by a modification of the RANO criteria that combined the image assessment, neurologic evaluation and assessment of steroid use. Clinical and radiologic assessments were carried out at pre-CCRT; 4 weeks after completion of the CCRT; and every 2 or 3 months during the adjuvant TMZ therapy. Complete Response (CR) was defined as complete disappearance on MR of all enhancing tumor; Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR by bi-dimensional measurement; Pseudoprogression was defined when there was a decrease or stabilization of the contrast-enhancing lesions for a minimum of six months and combined with no change in treatment/ or a increase in contrast-enhancing lesion on the first subsequent follow-up MR image, as long as it stabilized on the second follow-up and there was no need for treatment change. Responder = CR+PR+Pseudoprogression, Non-responder = Progression.

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 Response Evaluation Criteria in Solid Tumors (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.
Quantitative changes to tumor protein content and tumor acidosis
Amide proton transfer asymmetry (APTasym, %) from Chemical Exchange Saturation Transfer (CEST) Amine proton transfer asymmetry (AmPTasym %) from CEST
Quantitative changes to tumor cellularity
Apparent diffusion coefficient (ADC, mm2/s) from Diffusion weighted MRI
Quantitative changes to tumor perfusion using dynamic susceptibility contrast MRI
Normalized Cerebral blood volume (CBV, %) from dynamic susceptibility contrast (DSC)-MRI
Quantitative changes to tumor perfusion using dynamic contrast enhancement MRI
Initial area-under-the-curve (IAUC) from dynamic contrast enhancement (DCE)-MRI

Full Information

First Posted
November 18, 2015
Last Updated
April 3, 2023
Sponsor
Asan Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02613988
Brief Title
Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas
Official Title
Early Response Assessment Using on 3T Advanced MR Imaging as Predictor of Long-term Treatment Response in Newly Diagnosed Glioblastomas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2020 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial studies advanced MR imaging techniques in measuring early response of standard treatment may become predictors of long-term treatment response in patients with newly diagnosed glioblastomas.
Detailed Description
The standard care of patients with glioblastoma is concomitant chemoradiation and adjuvant temozolomide. Allowing for assessment of tumor therapy prior to treatment completion is important to select patients most likely to benefit from alternative treatment option. Multimodal advanced MR imaging- contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, chemical exchange saturation transfer imaging, and perfusion imaging on 3T enables quantitative assessment of treatment response. Quantifying changes in advanced MR imaging techniques would allow predict outcome for early and long-term treatment response and survival in glioblastomas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Glioblastoma
Keywords
Glioblastoma, MRI, standard treatment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MR imaging and standard treatment
Arm Type
Other
Arm Description
Patients with glioblastoma undergo 3-Tesla magnetic resonance imaging to measure tumor protein content (using CEST-MRI), cellularity (using DW-MRI), and perfusion (using DCE-MRI and DSC-MRI with IV administration of gadolinium-containing contrast agent) at pre-CCRT; 4 weeks after completion of the CCRT; and every 2 or 3 months during the adjuvant temozolomide therapy.
Intervention Type
Device
Intervention Name(s)
3 Tesla magnetic resonance imaging
Intervention Description
High resolution structural imaging (contrast-enhanced T1-weighted image, T2-weighted image, Fluid-attenuated inversion recovery)
Intervention Type
Device
Intervention Name(s)
Chemical exchange saturation transfer MRI
Intervention Description
Amide proton transfer-weighted image
Intervention Type
Device
Intervention Name(s)
Diffusion weighted MRI
Intervention Description
diffusion-weighted image with b value 0, 1000, and 3000
Intervention Type
Device
Intervention Name(s)
Dynamic susceptibility contrast MRI
Intervention Description
dual echo EPI sequence
Primary Outcome Measure Information:
Title
Diagnostic Performance of Response Rate
Description
The response was determined by a modification of the RANO criteria that combined the image assessment, neurologic evaluation and assessment of steroid use. Clinical and radiologic assessments were carried out at pre-CCRT; 4 weeks after completion of the CCRT; and every 2 or 3 months during the adjuvant TMZ therapy. Complete Response (CR) was defined as complete disappearance on MR of all enhancing tumor; Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR by bi-dimensional measurement; Pseudoprogression was defined when there was a decrease or stabilization of the contrast-enhancing lesions for a minimum of six months and combined with no change in treatment/ or a increase in contrast-enhancing lesion on the first subsequent follow-up MR image, as long as it stabilized on the second follow-up and there was no need for treatment change. Responder = CR+PR+Pseudoprogression, Non-responder = Progression.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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 Response Evaluation Criteria in Solid Tumors (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.
Time Frame
On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)
Title
Quantitative changes to tumor protein content and tumor acidosis
Description
Amide proton transfer asymmetry (APTasym, %) from Chemical Exchange Saturation Transfer (CEST) Amine proton transfer asymmetry (AmPTasym %) from CEST
Time Frame
Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Title
Quantitative changes to tumor cellularity
Description
Apparent diffusion coefficient (ADC, mm2/s) from Diffusion weighted MRI
Time Frame
Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Title
Quantitative changes to tumor perfusion using dynamic susceptibility contrast MRI
Description
Normalized Cerebral blood volume (CBV, %) from dynamic susceptibility contrast (DSC)-MRI
Time Frame
Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Title
Quantitative changes to tumor perfusion using dynamic contrast enhancement MRI
Description
Initial area-under-the-curve (IAUC) from dynamic contrast enhancement (DCE)-MRI
Time Frame
Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have radiologically and histologically confirmed diagnosis of newly diagnosed glioblastoma Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter Life expectancy of greater than 3 months Patients scheduled for standard therapy (6 weeks radiation treatment (RT) ~ 60 Gy, plus temozolomide 75 mg/m^2 during 6 week RT, and followed routine monthly temozolomide therapy) Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines Exclusion Criteria: Patients who underwent complete resection Patients with no evidence of measurable disease after surgery Patients who have had chemotherapy or radiotherapy Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Sung Kim, MD, PhD
Phone
+82230105682
Email
radhskim@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Eun Park, MD
Phone
+82230101505
Email
jieunp@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Sung Kim, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
21527563
Citation
Galban CJ, Chenevert TL, Meyer CR, Tsien C, Lawrence TS, Hamstra DA, Junck L, Sundgren PC, Johnson TD, Galban S, Sebolt-Leopold JS, Rehemtulla A, Ross BD. Prospective analysis of parametric response map-derived MRI biomarkers: identification of early and distinct glioma response patterns not predicted by standard radiographic assessment. Clin Cancer Res. 2011 Jul 15;17(14):4751-60. doi: 10.1158/1078-0432.CCR-10-2098. Epub 2011 Apr 28.
Results Reference
background
PubMed Identifier
25611736
Citation
Park JE, Kim HS, Goh MJ, Kim SJ, Kim JH. Pseudoprogression in Patients with Glioblastoma: Assessment by Using Volume-weighted Voxel-based Multiparametric Clustering of MR Imaging Data in an Independent Test Set. Radiology. 2015 Jun;275(3):792-802. doi: 10.1148/radiol.14141414. Epub 2015 Jan 21.
Results Reference
background
PubMed Identifier
26491847
Citation
Park JE, Kim HS, Park KJ, Kim SJ, Kim JH, Smith SA. Pre- and Posttreatment Glioma: Comparison of Amide Proton Transfer Imaging with MR Spectroscopy for Biomarkers of Tumor Proliferation. Radiology. 2016 Feb;278(2):514-23. doi: 10.1148/radiol.2015142979. Epub 2015 Aug 19.
Results Reference
background

Learn more about this trial

Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas

We'll reach out to this number within 24 hrs