Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma. (TIGRE)
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|ClinicalTrials.gov Identifier: NCT03739333|
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : June 20, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Other: 11C-Methionine PET-MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma.|
|Actual Study Start Date :||February 26, 2019|
|Estimated Primary Completion Date :||February 26, 2020|
|Estimated Study Completion Date :||January 26, 2025|
Experimental: patients with glioblastoma
implementation of 11C-Methionine PET-MRI
Other: 11C-Methionine PET-MRI
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.
- false negatives and false positives description (diagnosis accuracy) of 11C-Methionine PET-MRI [ Time Frame: within 1 months and 12 months post-treatment ]diagnosis accuracy of 11C-MET PET-MRI to differentiated pseudoprogression from tumor recurrence, compared to MRI. The gold-standard being retrospective MRI analysis.
- ROC curves for comparison of two diagnostic tests: MRI and PET-MRI [ Time Frame: within 1 months and 24 months after inclusion ]use of area under the curve for each tests to identify the best
- The proportion of pseudoprogression identified by PET-MRI to 11C-MET according to the genetic data [ Time Frame: during 24 months after inclusion ]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.
- Overall survival analysis [ Time Frame: during 24 months after inclusion ]Patients will be followed regularly for 2 years to assess overall survival at 12 months and at 24 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739333
|Contact: DUCRAY François, MD||00 (33) 4 72 68 13 email@example.com|
|Contact: ISAL Sibel, MD||00 (33) 4 72 35 76 firstname.lastname@example.org|
|Hopices Civils de Lyon||Recruiting|
|Bron, France, 69 677|
|Contact: DUCRAY François, MD 00 (33) 4 72 68 13 21 email@example.com|
|Contact: ISAL Sibel, MD 00 (33) 4 72 35 76 29 firstname.lastname@example.org|
|Principal Investigator:||DUCRAY François||Hospîces Civils de Lyon|