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

NCT02613988 | Recruiting DMC

• 1 other identifier: AsanMCHSKim_01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Glioblastoma

Keywords

Glioblastoma; MRI; standard treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  6 month

Secondary Outcomes (5)

• Progression Free Survival (PFS)

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

• Quantitative changes to tumor protein content and tumor acidosis

  Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT

• Quantitative changes to tumor cellularity

  Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT

• Quantitative changes to tumor perfusion using dynamic susceptibility contrast MRI

  Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT

• Quantitative changes to tumor perfusion using dynamic contrast enhancement MRI

  Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT

Study Arms (1)

MR imaging and standard treatment

OTHER

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.

Device: 3 Tesla magnetic resonance imaging; Device: Chemical exchange saturation transfer MRI; Device: Diffusion weighted MRI; Device: Dynamic susceptibility contrast MRI

Interventions

3 Tesla magnetic resonance imaging DEVICE

High resolution structural imaging (contrast-enhanced T1-weighted image, T2-weighted image, Fluid-attenuated inversion recovery)

MR imaging and standard treatment

Chemical exchange saturation transfer MRI DEVICE

Amide proton transfer-weighted image

MR imaging and standard treatment

Diffusion weighted MRI DEVICE

diffusion-weighted image with b value 0, 1000, and 3000

MR imaging and standard treatment

Dynamic susceptibility contrast MRI DEVICE

dual echo EPI sequence

MR imaging and standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Related Publications (4)

• 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.

  PMID: 21527563 BACKGROUND

• 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.

  PMID: 25611736 BACKGROUND

• 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.

  PMID: 26491847 BACKGROUND

• Moon HH, Park JE, Kim N, Kim YH, Song SW, Hong CK, Kim JH, Kim HS. Prospective longitudinal analysis of imaging-based spatiotemporal tumor habitats in glioblastoma, IDH-wild type: implication in patient outcome using multiparametric physiologic MRI. BMC Cancer. 2024 Sep 27;24(1):1197. doi: 10.1186/s12885-024-12939-7.

  PMID: 39334005 DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Diffusion Magnetic Resonance Imaging; Perfusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ho Sung Kim, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho Sung Kim, MD, PhD

CONTACT

+82230105682; radhskim@gmail.com

Ji Eun Park, MD

CONTACT

+82230101505; jieunp@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 25, 2015
• Study Start: January 12, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

KR (1)