Informations générales (source: ClinicalTrials.gov)
Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma. (TIGRE)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
février 2019
janvier 2025
01 février 2025
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).
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hopices Civils de Lyon - 69 677 - Bron - France | DUCRAY François, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patients aged 18 or over,
- Patient with glioblastoma treated by radiochemotherapy with temozolomide,
- Patient with suspicion of pseudoprogression between the 1st and 12th month after the
end of concomitant chemoradiotherapy,
- Patient receiving a social security scheme,
- Patient for whom informed and written consent to participate has been obtained,
- Patients aged 18 or over,
- Patient with glioblastoma treated by radiochemotherapy with temozolomide,
- Patient with suspicion of pseudoprogression between the 1st and 12th month after the
end of concomitant chemoradiotherapy,
- Patient receiving a social security scheme,
- Patient for whom informed and written consent to participate has been obtained,
- Subject under safeguard of justice (tutelage, curatorship),
- Minor patient,
- Patient without signs of progression MRI (stable disease or good response to
treatment according to the RANO 2010 criteria),
- Clinical or radiological progression justifying a change of treatment,
- Patient not able to decide and with refusal of the family entitled to continue
research.
- Pregnant woman, breastfeeding or old enough to have children but without effective
contraception,
- Contraindication to performing an MRI: permanently fixed metal parts (pacemaker,
cerebral clip, cochlear implant, pin or screw for recent bone fracture, dental
equipment, metal splinters), claustrophobia,
- Contraindication to gadolinium according to ANSM 2017 recommendations