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This study aims to evaluate whether pre-treatment MRI can be used to predict treatment response for anti-angiogenic treatment in glioblastomas.
Although overall the effects on prolonging survival in bevacizumab-treated patients is modest at best, it is still unclear whether there is not a more substantial positive effect in a subset of patients, potentially identifiable by imaging markers. Allowing for prediction of good or bad responder from anti-angiogenic therapy prior to treatment completion is important to select patients most likely to benefit from anti-angiogenic treatment.
This is a prospective observational study and no active comparator will be used. Study participants include adult patients with recurrent glioblastoma.
We hypothesized that quantifying changes in multi-modal advanced MR imaging techniques would allow early treatment response and long-term prediction in glioblastomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Received bevacizumab treatment | Recurrent glioblastoma patients with received anti-angiogenic treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-Tesla conventional magnetic resonance imaging | Diagnostic Test | T1-weighted, T2-weighted, fluid-attenuated inversion recovery, and contrast-enhanced T1-weighted imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Time from anti-angiogenic treatment until death or the first imaging report indicating worsening/progression. | Average 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month progression | Pathologic confirmation following second look surgery or clinico-radiological assessment at 6-month | 6 month |
| Overall survival | Time from anti-angiogenic treatment to death |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of tertiary medical center
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| Name | Affiliation | Role |
|---|---|---|
| Ho Sung Kim, M.D.,Ph.D. | Department of Radiology, Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21282590 | Background | Pope WB, Xia Q, Paton VE, Das A, Hambleton J, Kim HJ, Huo J, Brown MS, Goldin J, Cloughesy T. Patterns of progression in patients with recurrent glioblastoma treated with bevacizumab. Neurology. 2011 Feb 1;76(5):432-7. doi: 10.1212/WNL.0b013e31820a0a8a. | |
| 28655794 | Result | Ellingson BM, Gerstner ER, Smits M, Huang RY, Colen R, Abrey LE, Aftab DT, Schwab GM, Hessel C, Harris RJ, Chakhoyan A, Gahrmann R, Pope WB, Leu K, Raymond C, Woodworth DC, de Groot J, Wen PY, Batchelor TT, van den Bent MJ, Cloughesy TF. Diffusion MRI Phenotypes Predict Overall Survival Benefit from Anti-VEGF Monotherapy in Recurrent Glioblastoma: Converging Evidence from Phase II Trials. Clin Cancer Res. 2017 Oct 1;23(19):5745-5756. doi: 10.1158/1078-0432.CCR-16-2844. Epub 2017 Jun 27. |
| Label | URL |
|---|---|
| Actual publication results | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Clinical Study Report | View IPD |
Data sharing if raw imaging data outside Korea is prohibited by Korean government. For anonymized imaging data, part of cases may be feasible on the approval of the principle investigator.
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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 |
|---|---|
| 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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| Advanced imaging without contrast use | Diagnostic Test | Diffusion-weighted imaging, amide proton transfer-weighted imaging, electrical properties tomography, and 2hG-magnetic resonance spectroscopy |
|
| Dynamic susceptibility contrast-weighted imaging | Diagnostic Test | Cerebral blood volume and vessel architectural imaging parameters |
|
| Average 12 months |
| 25646027 | Result | Schmainda KM, Zhang Z, Prah M, Snyder BS, Gilbert MR, Sorensen AG, Barboriak DP, Boxerman JL. Dynamic susceptibility contrast MRI measures of relative cerebral blood volume as a prognostic marker for overall survival in recurrent glioblastoma: results from the ACRIN 6677/RTOG 0625 multicenter trial. Neuro Oncol. 2015 Aug;17(8):1148-56. doi: 10.1093/neuonc/nou364. Epub 2015 Feb 2. |
| 26491847 | Result | 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. |
| 23955713 | Result | Emblem KE, Mouridsen K, Bjornerud A, Farrar CT, Jennings D, Borra RJ, Wen PY, Ivy P, Batchelor TT, Rosen BR, Jain RK, Sorensen AG. Vessel architectural imaging identifies cancer patient responders to anti-angiogenic therapy. Nat Med. 2013 Sep;19(9):1178-83. doi: 10.1038/nm.3289. Epub 2013 Aug 18. |
| 36242633 | Derived | Kim M, Park JE, Yoon SK, Kim N, Kim YH, Kim JH, Kim HS. Vessel size and perfusion-derived vascular habitat refines prediction of treatment failure to bevacizumab in recurrent glioblastomas: validation in a prospective cohort. Eur Radiol. 2023 Jun;33(6):4475-4485. doi: 10.1007/s00330-022-09164-w. Epub 2022 Oct 15. |
Vessel size and perfusion-derived vascular habitat refines prediction of treatment failure to bevacizumab in recurrent glioblastomas: validation in a prospective cohort |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D003933 | Diagnosis |