Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma.

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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,
Exclusion Criteria:
- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03739333
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hospices Civils de Lyon
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	DUCRAY François
Principal Investigator Affiliation	Hospîces Civils de Lyon
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Arms & Interventions

Arms

Experimental: patients with glioblastoma

implementation of 11C-Methionine PET-MRI

Interventions

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.

Contact a Trial Team

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International Sites

Hopices Civils de Lyon, Bron, France

Status

Recruiting

Address

Hopices Civils de Lyon

Bron, , 69 677

Site Contact

DUCRAY François, MD

[email protected]

00 (33) 4 72 68 13 21

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