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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 Tesla magnetic resonance imaging | Device | High resolution structural imaging (contrast-enhanced T1-weighted image, T2-weighted image, Fluid-attenuated inversion recovery) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ho Sung Kim, MD, PhD | Contact | +82230105682 | radhskim@gmail.com | |
| Ji Eun Park, MD | Contact | +82230101505 | jieunp@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ho Sung Kim, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21527563 | Background | 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. | |
| 25611736 |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D038524 | Diffusion Magnetic Resonance Imaging |
| D000098642 | Perfusion Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Chemical exchange saturation transfer MRI | Device | Amide proton transfer-weighted image |
|
| Diffusion weighted MRI | Device | diffusion-weighted image with b value 0, 1000, and 3000 |
|
| Dynamic susceptibility contrast MRI | Device | dual echo EPI sequence |
|
| 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 | 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 26491847 | 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. |
| 39334005 | Derived | 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. |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D003933 | Diagnosis |