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

Primary Purpose

High-grade Glioma

Status
Terminated
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
C13 N15 Valine
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for High-grade Glioma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CLINATEC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C13 N15 Valine

Arm Description

Intervention C13 N15 Valine

Outcomes

Primary Outcome Measures

Mass spectrometry measurement of C13 labelled proteins

Secondary Outcome Measures

Full Information

First Posted
November 20, 2014
Last Updated
May 3, 2018
Sponsor
University Hospital, Grenoble
Collaborators
National Cancer Institute, France
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1. Study Identification

Unique Protocol Identification Number
NCT02305056
Brief Title
Study of Tumor Metabolism by Isotopic Tagging in Patients With High-grade Glioma (CARBONOMIC)
Acronym
CARBONOMIC
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
January 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
National Cancer Institute, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-grade Glioma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C13 N15 Valine
Arm Type
Experimental
Arm Description
Intervention C13 N15 Valine
Intervention Type
Drug
Intervention Name(s)
C13 N15 Valine
Other Intervention Name(s)
CARBONOMIC
Intervention Description
C13 N15 Valine administration
Primary Outcome Measure Information:
Title
Mass spectrometry measurement of C13 labelled proteins
Time Frame
during 30 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François BERGER, Pr
Organizational Affiliation
University Grenoble Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CLINATEC
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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