Study of Tumor Metabolism by Isotopic Tagging in Patients With High-grade Glioma (CARBONOMIC)

High-grade Glioma Clinical Trial

— CARBONOMIC  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02305056
• Other study ID #: CARBONOMIC
• Status: Terminated
• Phase: Phase 1
• Start date: September 2014
• Est. completion date: January 30, 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive isotopic tagging (carbon 13 and nitrogen 15).

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 information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• High-grade Glioma

Intervention

Drug:
• C13 N15 Valine
C13 N15 Valine administration

Locations

Country	Name	City	State
France	CLINATEC	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass spectrometry measurement of C13 labelled proteins		during 30 hours