GlioblastomaSPECTROBEVANCT03144167
Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy
A study testing Analysis of spectroscopic biomarkers of proliferation for six-month survival in people with Glioblastoma and Radiotherapy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Radiotherapy, Chemotherapy
- What is being tested?
- Analysis of spectroscopic biomarkers of proliferation for six-month survival
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2019to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 ...
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Jean-Marc CONSTANS, PhD, +33322087511, constans.jean-marc@chu-amiens.fr
About this study
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
- Conditions
- Glioblastoma, Radiotherapy, Chemotherapy
- Being tested
- Analysis of spectroscopic biomarkers of proliferation for six-month survival
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of spectroscopic biomarkers of proliferation for six-month survivalOther
Analysis of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism for six-month survival
| Study group | Role | What they receive |
|---|---|---|
| Patients, aged 18-88, with glioblastoma | Other | Not described Receives: Other: Analysis of spectroscopic biomarkers of proliferation for six-month survival |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze 6-month survival defined as the time between inclusion in the protocol and death
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start18 Jun 2019
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144167
- Sponsor's protocol ID
- PI2016_843_0027
- Acronym
- SPECTROBEVA
- Status last verified
- Jan 2026
- First submitted
- 27 Apr 2017
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy
- ClinicalTrials.gov ID
- NCT03144167
- Acronym / sponsor ID
- SPECTROBEVA / PI2016_843_0027
- Conditions
- Glioblastoma, Radiotherapy, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients, aged 18-88, with glioblastoma | Other | Other: Analysis of spectroscopic biomarkers of proliferation for six-month survival |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients, between 18 and 88 years, with glioblastoma (histologically proven) in first relapse after conventional treatment by surgery and temozolomide and radiotherapy
- Biological Criteria
Key exclusion criteria (26 listed)
- Patients who can not benefit from bevacizumab for the following reasons:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of spectroscopic biomarkers of proliferation for six-month survivalAnalysis of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism for six-month survival | Other | Patients, aged 18-88, with glioblastoma |
Primary outcome
Analyze 6-month survival defined as the time between inclusion in the protocol and death
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of spectroscopic biomarkers of proliferation for six-month survival in people with Glioblastoma and Radiotherapy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marc CONSTANS, PhD (+33322087511, constans.jean-marc@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze 6-month survival defined as the time between inclusion in the protocol and death (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.