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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002016-27 | EudraCT Number |
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Pseudoprogression is a phenomenon related to post-treatment rearrangements (including radiation necrosis). It appears early in the first year after treatment and accounts for 30 to 50% of patients followed with glioblastoma. On MRI (current gold standard with international therapeutic response evaluation criteria RANO 2010), pseudoprogression is manifested by a progression of morphological abnormalities (contrast enhancement, FLAIR hypersignal) and can simulate tumor recurrence, even though the corticosteroid improved or kept clinical symptoms stabilized. In view of prognosis, the current diagnostic tools have not enough diagnosis accuracy for differentiation between pseudo-progression and early tumor recurrence, and are based on MRI retrospective analysis (2-3 months after). Recurrence of glioblastoma, is characterized by a higher amino acid metabolism than pseudoprogression, also 11C-Methionine (11C-MET), positron emitting radiotracer, showed promising results to differentiate these two entities. To date, hybrid 11C-MET PET-MRI studies remains limited to small sample size (a few dozen patients), and none focuses exclusively on glioblastoma.
Hypothesis of our study is that 11C-MET PET-MRI may be performed as a first-line MRI for suspected pseudoprogression and may changes therapeutic decision making and also patient prognosis.
The main objective is to evaluate the performance of hybrid PET-MRI imaging with 11C-MET to differentiate pseudoprogression from glioblastoma recurrence in patients treated with surgery and radiochemotherapy, compared to multimodality MRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with glioblastoma | Experimental | implementation of 11C-Methionine PET-MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11C-Methionine PET-MRI | Other | Implementation 11C-Methionine PET-MRI performed for each patient in one place (department of nuclear medicine of Hospices Civils de Lyon). The 11C-Methionine PET-MRI will be performed after radiochemotherapy in patients with MRI suspicious of pseudoprogression. |
| Measure | Description | Time Frame |
|---|---|---|
| false negatives and false positives description (diagnosis accuracy) of 11C-Methionine PET-MRI | diagnosis accuracy of 11C-MET PET-MRI to differentiated pseudoprogression from tumor recurrence, compared to MRI. The gold-standard being retrospective MRI analysis. | within 1 months and 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| ROC curves for comparison of two diagnostic tests: MRI and PET-MRI | use of area under the curve for each tests to identify the best | within 1 months and 24 months after inclusion |
| The proportion of pseudoprogression identified by PET-MRI to 11C-MET according to the genetic data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DUCRAY François, MD | Contact | 00 (33) 4 72 68 13 21 | francois.ducray@chu-lyon.fr | |
| ISAL Sibel, MD | Contact | 00 (33) 4 72 35 76 29 | sibel.isal@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| DUCRAY François | Hospîces Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopices Civils de Lyon | Recruiting | Bron | 69 677 | France |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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The proportion of pseudoprogression identified by PET-MRI to 11C-MET according to the methylation status of the O6-methylguanine-DNA- methyltransferase (MGMT) promoter, the level of expression of isocitrate dehydrogenase (IDH) mutation, ki67 and 1p19q mutation. |
| during 24 months after inclusion |
| Overall survival analysis | Patients will be followed regularly for 2 years to assess overall survival at 12 months and at 24 months. | during 24 months after inclusion |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D007154 | Immune System Diseases |