Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy (SPECTROBEVA)

January 15, 2026 updated by: Centre Hospitalier Universitaire, Amiens

No predictive factors are known for the response to the bevacizumab anti-angiogenic molecule (Avastin) given in the event of relapse of glioblastoma (GBM) following radiochemotherapy. Classical MRI with gadolinium injection and perfusion is not sufficient to predict survival and response or duration. We propose to evaluate the prognostic interest for 6-month survival of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism recorded at 7 and 28 days of application of the treatment.

These biomarkers are based on the increase of an index combining choline / Creatine (Cho / Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine) and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed GBM patients at an early stage and to identify responder patients who would benefit from this expensive molecule and avoid using it in non-responding patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients, between 18 and 88 years, with glioblastoma (histologically proven) in first relapse after conventional treatment by surgery and temozolomide and radiotherapy

  • Biological Criteria

    • Polymorphonuclear neutrophils> 1500 / mm3
    • Plates> 100,000 / mm3
    • SGOT-SGPT <5 at the upper limit of normal (ULN)
    • Bilirubin <1.5 x ULN
    • Creatinine <1.5 LSN and creatinine clearance
    • Proteinuria <1 g / 24 hours
    • Patient with health insurance
    • Consent signed by the patient if he is lucid, or failing that by the person of trust

Exclusion Criteria:

  • Patients who can not benefit from bevacizumab for the following reasons:

    • Symptomatic cerebral or tumor hemorrhage
    • Karnofsky Index less than 50% or
  • Patients already treated with an antiangiogenic molecule or Gliadel (diagnosis and recurrence).
  • Coagulation disorders in case of injectable treatment (especially for avastin),
  • Contraindications known to the MRI: Pace Makers, foreign bodies intraocular, electrodes ...
  • Uncontrolled severe concomitant pathology, including another evolving cancer (with the exception of operative cutaneous tumors, in situ cancer of the cervix or breast treated).
  • Uncontrolled Infection
  • Uncontrolled hypertension (PAS> 160 mm Hg) despite optimized treatment
  • Coronary artery disease or unstable arterial disease. Evolutionary aneurysm.
  • Myocardial infarction dating from less than 6 months.
  • Peripheral arterial or cerebrovascular accident occurring less than 6 months.
  • Heart Failure> grade II NYHA
  • Hemorrhagic Disease (Hemophilia, Willebrandt ...)
  • Nephrotic syndrome with proteinuria> 2 g / 24 h
  • History of haemoptysis dating less than 1 month.
  • Pulmonary embolism dating less than 1 month.
  • Surgical intervention (other than craniotomy or stereotactic biopsy) dating less than one month or essential and predictable surgery.
  • History of digestive fistula or intestinal perforation with resolution less than 6 months.
  • Hypersensitivity to bevacizumab or to any of the excipients mentioned in Composition.
  • Hypersensitivity to Chinese hamster ovary (CHO) cells or to other human or humanized recombinant antibodies.
  • Severe Myelosuppression
  • Pregnant or nursing. Contraception should be prescribed if necessary during treatment.
  • Persons deprived of liberty or placed under safeguard of justice (guardianship or curatorship),
  • Subject involved in another search including an exclusion period still in progress at pre-inclusion
  • Patient refusing to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients, aged 18-88, with glioblastoma
Other: Analysis of spectroscopic biomarkers of proliferation for six-month survival
Analysis of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism for six-month survival

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analyze 6-month survival defined as the time between inclusion in the protocol and death
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2019

Primary Completion (Estimated)

January 20, 2027

Study Completion (Estimated)

January 20, 2027

Study Registration Dates

First Submitted

April 27, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2016_843_0027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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