Clinical trial · Interventional
Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas
Early Response Assessment Using on 3T Advanced MR Imaging as Predictor of Long-term Treatment Response in Newly Diagnosed Glioblastomas
NCT02613988CI-TRIAL-00077100unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3 Tesla magnetic resonance imaging | Device | — | UNRESOLVED |
| Chemical exchange saturation transfer MRI | Device | — | UNRESOLVED |
| Diffusion weighted MRI | Device | — | UNRESOLVED |
| Dynamic susceptibility contrast MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MR imaging and standard treatment
- 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.
- interventionNames
- Device: 3 Tesla magnetic resonance imaging
- Device: Chemical exchange saturation transfer MRI
- Device: Diffusion weighted MRI
- Device: Dynamic susceptibility contrast MRI
Primary outcomes (1)
- measure
- Diagnostic Performance of Response Rate
- timeFrame
- 6 month
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDGalban 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
- BACKGROUNDPark 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
- BACKGROUNDPark 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
- DERIVEDMoon 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