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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02305056

Acronym

CARBONOMIC

Enrollment

Registered

2014-12-02

Start date

2014-09-30

Completion date

2018-01-30

Last updated

2018-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-grade Glioma

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.

Interventions

DRUGC13 N15 Valine

C13 N15 Valine administration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mass spectrometry measurement of C13 labelled proteins	during 30 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026