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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Terminated
Phase 1

Conditions

High-grade Glioma

Treatments

Drug: C13 N15 Valine

Study type

Interventional

Funder types

Other

Identifiers

NCT02305056
CARBONOMIC

Details and patient eligibility

About

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

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

C13 N15 Valine
Experimental group
Description:
Intervention C13 N15 Valine
Treatment:
Drug: C13 N15 Valine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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