NCT02305056

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

3.4 years

First QC Date

November 20, 2014

Last Update Submit

May 3, 2018

Conditions

High-grade Glioma

Outcome Measures

Primary Outcomes (1)

  • Mass spectrometry measurement of C13 labelled proteins

    during 30 hours

Study Arms (1)

C13 N15 Valine

EXPERIMENTAL

Intervention C13 N15 Valine

Drug: C13 N15 Valine

Interventions

C13 N15 ValineDRUG

C13 N15 Valine administration

Also known as: CARBONOMIC
C13 N15 Valine

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CLINATEC

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • François BERGER, Pr

    University Grenoble Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2014

First Posted

December 2, 2014

Study Start

September 1, 2014

Primary Completion

January 30, 2018

Study Completion

January 30, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

FR(1)