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

Adult Glioblastoma Clinical Trial

Official title:

Early Response Assessment Using on 3T Advanced MR Imaging as Predictor of Long-term Treatment Response in Newly Diagnosed Glioblastomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02613988
• Other study ID #: AsanMCHSKim_01
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2020
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Asan Medical Center
• Contact: Ho Sung Kim, MD, PhD
• Phone: +82230105682
• Email: radhskim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Glioblastoma
• Glioblastoma

Intervention

Device:
• 3 Tesla magnetic resonance imaging
High resolution structural imaging (contrast-enhanced T1-weighted image, T2-weighted image, Fluid-attenuated inversion recovery)
• Chemical exchange saturation transfer MRI
Amide proton transfer-weighted image
• Diffusion weighted MRI
diffusion-weighted image with b value 0, 1000, and 3000
• Dynamic susceptibility contrast MRI
dual echo EPI sequence

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)
Secondary	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	Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Secondary	Quantitative changes to tumor cellularity	Apparent diffusion coefficient (ADC, mm2/s) from Diffusion weighted MRI	Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Secondary	Quantitative changes to tumor perfusion using dynamic susceptibility contrast MRI	Normalized Cerebral blood volume (CBV, %) from dynamic susceptibility contrast (DSC)-MRI	Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Secondary	Quantitative changes to tumor perfusion using dynamic contrast enhancement MRI	Initial area-under-the-curve (IAUC) from dynamic contrast enhancement (DCE)-MRI	Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT