Study of Tumor Metabolism by Isotopic Tagging in Patients With High-grade Glioma (CARBONOMIC)
Phase 1
Terminated
- Conditions
- High-grade Glioma
- Interventions
- Drug: C13 N15 Valine
- Registration Number
- NCT02305056
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive isotopic tagging (carbon 13 and nitrogen 15).
- Detailed Description
The project aims to study protein turnover in glioblastoma using mass spectrometry after 13C-valine incorporation. This will allow to identify proteins in circulation secreted by tumor which could be diagnostic and pronostic biomarkers in patients With High-grade Glioma.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
-
more or equal than 18 years old
-
patient affiliated to social security or similarly regime
-
informed consent form signed
-
High-grade Glioma tumor suspicion
-
Resective surgery indication
-
Hematological assessment :
- neutrophils > 1500/mm3
- Platelet > 150 000
- blood Creatinin normal
- alkaline Phosphatases and transaminases no more than two times normal
- Bilirubin < 1.5 times normal
Exclusion Criteria
- Pregnant women and lactating mothers
- Ward of court or under guardianship
- Adult unable to express their consent
- Person deprived of freedom by judicial or administrative decision
- Person hospitalized without their consent
- Person under legal protection
- Precedent complete macroscopic tumor resective surgery
- No valid inclusion criteria
- Intratumoral hemorrhage MRI detected
- Treatment anticoagulant or antisludge treatments
- Active Infections and non controled or medical affection or psychiatric intercurrent non treated
- Evolutive cerebral oedema without corticoid response
- Non controled Epilepsy without antiepileptics response
- Karnofsky score < 40%
- Weight > 100 kg
- No possibility of resective surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description C13 N15 Valine C13 N15 Valine Intervention C13 N15 Valine
- Primary Outcome Measures
Name Time Method Mass spectrometry measurement of C13 labelled proteins during 30 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CLINATEC
🇫🇷Grenoble, France