Brain Arteriovenous MalformationsPhase 1BLITZNCT07075757
In Situ Injection of Anti-angiogenics in Patients With Brain Arteriovenous Malformations Not Eligible for Exclusion Treatment
A Phase 1 study testing Single in situ intra-arterial injection of bevacizumab in people with Brain Arteriovenous Malformations, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
Trial summary
Brain arteriovenous malformations (bAVMs) are rare aggressive vascular malformations affecting mostly young and healthy adults. The most frequent revealing condition (in almost 50% of cases) is an intra-cerebral hemorrhage, which is a considerable source of disability and mortality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Arteriovenous Malformations
- What is being tested?
- Single in situ intra-arterial injection of bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Oct 2025to 1 Nov 2028
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and < 65 years at the time of inclusion
- bAVM (i.e.: located in the brain, brain stem or cerebellum)
- Spetzler-Martin grade IV - V on a brain MRI performed less than 2 months before inclusion
- History of rupture and/or with intractable symptoms related to the bAVM (i.e.: intractable seizure, steal phenomenon, compressive symptoms)
- bAVM deemed unsuitable for exclusion invasive treatment
- Adequate bone marrow function at inclusion :
Show all 15Show fewer
- Hemoglobin (Hb) levels more than 13.5 g/dL in males and Hb levels more than 12.5 g/dL in females.
- Platelet count ≥ 150 G/L
- Leukocytes count ≥ 3000/μL
- Neutrophils count ≥ 1500/μL
- Normal liver function (alanine transaminase [ALT] < 56 UI/L and aspartate aminotransferase [AST] < 40 UI/L) at inclusion
- Normal renal function (creatinine clearance ≥ 30 ml/min calculated with the Cockcroft-Gault formula) at inclusion
- Complete COVID-19 vaccinal scheme, according to the French recommendations
- Affiliation to French Healthcare system (AME excluded)
- Signed informed consent
Who cannot join
- Diffuse bAVM (like proliferative angiopathy) that cannot be assessed in terms of volume by cross-sectional imaging on MRI
- Inability/contraindication to undergo MRI (Pacemaker, iron metallic items, cochlear implants, claustrophobia)
- Coagulation disorders (prothrombin time < 50% or Platelet count < 150 G/L)
- Any congenital predisposition to coagulation disorder
- Any disease requiring full anticoagulation
- History of cancer, except baso-cellular carcinoma
Show all 25Show fewer
- Congestive cardiac failure
- Pre-existing coronary disease
- Unstable medical or psychiatric illness
- Any history of clinically significant thrombotic episode within the last 6 months
- Any history of atrial fibrillation
- Proteinuria (albumin excretion rate > 30 mg/day)
- Blood hypertension grade ≥ II (CTACE v5.0, 2017)
- Past history of a gastro-intestinal fistula
- Past history of a vaginal fistula
- Past history of open surgery within the last 28 days
- Infectious syndrome within the last month
- Any other contra-indication to bevacizumab administration
- Any contra-indication to general anesthesia
- Pregnancy or lactating woman
- Woman without efficacy contraception (combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence) all along study participation, and until 6 months after the bevacizumab administration, for woman of childbearing potential
- Seropositivity for HIV, HCV or HBV
- Severe and proven allergy to iodinated contrast material or Gadolinium
- Participation in another interventional clinical trial evaluating a health product or any randomized clinical trial
- Patients under legal protection (tutorship or curatorship) and patient deprived of freedom
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites
CHU de Limoges, Hôpital Dupuytren
Limoges, 87000
Charbel Mounayer, professor, neuro-radiologie@chu-limoges.fr
Charbel MOUNAYER, Professor
CHU de Nancy, Hôpital Central
Nancy, 54000
Réné ANXIONNAT, Doctor, r.anxionnat@chru-nancy.fr
Réné Anxionnat, Doctor
APHP, Hôpital Pitié-Salpêtrière
Paris, 75013
Frédéric Clarençon, professor, + 33 1 42 16 35 43, frederic.clarencon@aphp.fr
Frédéric Clarençon, Professor
Centre Hospitalier Sainte-Anne
Paris, 75014
Olivier NAGGARA, Doctor, O.NAGGARA@ghu-paris.fr
Olivier NAGGARA, Doctor
CHU de Rouen, Hôpital Charles-Nicolle
Rouen, 76000
Chrysanthi Papagiannaki, Doctor, c.papagiannaki@chu-rouen.fr
Chrysanthi Papagiannaki, Doctor
About this study
Official title: In Situ Injection of Anti-angiogenics in Patients With Brain Arteriovenous Malformations Not Eligible for Exclusion Treatment: Phase I Trial
Brain arteriovenous malformations (bAVMs) are rare aggressive vascular malformations affecting mostly young and healthy adults. The most frequent revealing condition (in almost 50% of cases) is an intra-cerebral hemorrhage, which is a considerable source of disability and mortality. The only way to prevent a bleeding or a rebleeding is to perform an exclusion treatment (endovascular embolization, microsurgery, stereotactic radiosurgery, or a combination of these techniques). The major drawback of these treatments is the risk of severe complications, which can reach 20%, especially in patients presenting a bAVM with complex angio-architecture (i.e., grade IV to V in the Spetzler Martin grading scale). There is a growing evidence about the strong implication of angiogenesis (mainly mediated by the type A vascular endothelial growth factor [VEGF-A]) on the size and growth of the bAVM and even in the occurrence of bleeding events. Our hypothesis is that an in situ injection of bevacizumab, a monoclonal antibody inhibiting VEGF-A, in patients with bAVM deemed not suitable for exclusion treatment may be safe and help to reduce the nidus volume.
Read the detailed description
The main objective of this trial is to evaluate the tolerance of 3 escalating doses of an in situ intra-arterial injection of bevacizumab in patients with a brain arteriovenous malformation (bAVM) considered non-suitable for an exclusion treatment to determine the Maximum Tolerated Dose (MTD) using the Dose-Limiting Toxicity rate (DLT) at 30 days after the injection. The dose limiting toxicity (DLT) is defined as the occurrence within 30 days of the in-situ injection of bevacizumab of one of the following events: Symptomatic venous/arterial thromboembolic events (symptomatic pulmonary embolism, symptomatic deep venous thrombosis, symptomatic ischemic stroke related to an arterial occlusion); Severe cytopenia defined as follows: Anemia defined as hemoglobin (Hb) level less than 8.0 g/dL (grade ≥ III, according to the CTCAE v5.0, 2017) Thrombocytopenia < 50 G/L (grade ≥ III, according to the CTCAE v5.0, 2017), Neutropenia < 1000/μL (grade ≥ IV according to the CTCAE v5.0, 2017); hypertension grade ≥ III (CTCAE v5.0, 2017); symptomatic intracranial hemorrhage resulting in transcient or permanent neurological deficit; any bleeding requiring transfusion; leukoencephalopathy grade ≥ III (CTCAE v5.0, 2017); Onset of intractable seizures ≥ Grade III (CTCAE v5.0, 2017); thrombo-embolic complication during the endovascular procedure leading to permanent deficit or to death; Intracranial arterial perforation with the microcatheter or the microguide wire during the endovascular procedure resulting in severe symptomatic hemorrhage (disability or death); any other serious adverse reaction (any untoward medical occurrence in a subject, to whom the medicinal product is administered, and which have a causal relationship with this treatment) resulting in any disability or death.
The secondary objectives and endpoints are to evaluate 1) the tolerance of 3 escalating doses of an in situ intra-arterial injection of bevacizumab in patients with a bAVM considered non-suitable for an exclusion treatment up to 12 months of follow-up; 2) To evaluate the efficacy of an in situ intra-arterial injection of bevacizumab in patients with a bAVM considered non-suitable for an exclusion treatment in terms of :Nidus volume size reduction at 6 and 12 months, Occurrence of cerebral bleeding events up to 12 months, Occurrence of seizures up to 12 months
- Conditions
- Brain Arteriovenous Malformations
- Being tested
- Single in situ intra-arterial injection of bevacizumab
- Keywords
- Brain arteriovenous malformations (bAVM), in situ intra-arterial injection, Bevacizumab
- Medical subject headings
- Intracranial Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single in situ intra-arterial injection of bevacizumabDrug
3 Escalating doses of an in situ intra-arterial injection of Bevacizumab (5 mg/kg, 7.5 mg/kg, 10 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Single in situ intra-arterial injection of bevacizumab | Experimental | 3 Escalating doses of an in situ intra-arterial injection of Bevacizumab (5 mg/kg, 7.5 mg/kg, 10 mg/kg) Receives: Drug: Single in situ intra-arterial injection of bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
Dose limiting toxicity defined as the occurrence within 30 days of the in situ injection of bevacizumab of one of the following events:
- Symptomatic venous/arterial thromboembolic events : pulmonary embolism, deep venous thrombosis, ischemic stroke, related to an arterial occlusion
- Severe cytopenia defined as:Anemia defined as hemoglobin level less than 8.0 g/dL grade ≥ III,Thrombocytopenia < 50 G/L grade ≥ III
- Neutropenia < 1000/μ L grade ≥ IV
- Hypertension grade ≥ III
- Symptomatic intracranial hemorrhage, resulting in transient/permanent neurological deficit
- Any bleeding requiring transfusion
- Leukoencephalopathy grade ≥ III
- Onset of intractable seizures ≥ Grade III
- Thrombo-embolic complication during the procedure leading to permanent deficit/death
- Intracranial arterial perforation with the microcatheter/ microguide wire resulting in symptomatic hemorrhage causing any disability/death.
- Any other serious adverse reaction resulting in any disability or death
Measured: Days 0 (day of the injection) to day 30
Secondary outcomes (4)
Tolerance of escalating doses (3+3) of an in situ intra-arterial injection of bevacizumab
Incidence and severity of adverse events
Measured: Days 0 (day of the injection) to 12 months
Reduction of the nidus volume
Nidus volume size reduction as compared with baseline assessment evaluated on MRI (3D GE T1-weighted images with IV Gadolinium)
Measured: at 6 and 12 months
Occurrence of an intra-cerebral bleeding event
Occurrence of intra-cerebral bleeding events from the AVM
Measured: Days 0 (day of the injection) to 12 months
Occurrence of at least one seizure
Occurrence of seizures
Measured: Days 0 (day of the injection) to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Arteriovenous MalformationsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Clarençon, Professor, Principal investigator, Pitié-Salpêtrière Hospital, AP-HP - Neuroradiology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075757
- Sponsor's protocol ID
- APHP211033
- Other IDs
- 2023-506991-28-00, 2023
- Acronym
- BLITZ
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Situ Injection of Anti-angiogenics in Patients With Brain Arteriovenous Malformations Not Eligible for Exclusion Treatment: Phase I Trial
- ClinicalTrials.gov ID
- NCT07075757
- Acronym / sponsor ID
- BLITZ / APHP211033
- Conditions
- Brain Arteriovenous Malformations
- Keywords
- Brain arteriovenous malformations (bAVM), in situ intra-arterial injection, Bevacizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 20 Jul 2025 (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.
Brain arteriovenous malformations (bAVMs) are rare aggressive vascular malformations affecting mostly young and healthy adults. The most frequent revealing condition (in almost 50% of cases) is an intra-cerebral hemorrhage, which is a considerable source of disability and mortality. The only way to prevent a bleeding or a rebleeding is to perform an exclusion treatment (endovascular embolization, microsurgery, stereotactic radiosurgery, or a combination of these techniques). The major drawback of these treatments is the risk of severe complications, which can reach 20%, especially in patients presenting a bAVM with complex angio-architecture (i.e., grade IV to V in the Spetzler Martin grading scale). There is a growing evidence about the strong implication of angiogenesis (mainly mediated by the type A vascular endothelial growth factor [VEGF-A]) on the size and growth of the bAVM and even in the occurrence of bleeding events. Our hypothesis is that an in situ injection of bevacizumab, a monoclonal antibody inhibiting VEGF-A, in patients with bAVM deemed not suitable for exclusion treatment may be safe and help to reduce the nidus volume.
Detailed description
The main objective of this trial is to evaluate the tolerance of 3 escalating doses of an in situ intra-arterial injection of bevacizumab in patients with a brain arteriovenous malformation (bAVM) considered non-suitable for an exclusion treatment to determine the Maximum Tolerated Dose (MTD) using the Dose-Limiting Toxicity rate (DLT) at 30 days after the injection. The dose limiting toxicity (DLT) is defined as the occurrence within 30 days of the in-situ injection of bevacizumab of one of the following events: Symptomatic venous/arterial thromboembolic events (symptomatic pulmonary embolism, symptomatic deep venous thrombosis, symptomatic ischemic stroke related to an arterial occlusion); Severe cytopenia defined as follows: Anemia defined as hemoglobin (Hb) level less than 8.0 g/dL (grade ≥ III, according to the CTCAE v5.0, 2017) Thrombocytopenia < 50 G/L (grade ≥ III, according to the CTCAE v5.0, 2017), Neutropenia < 1000/μL (grade ≥ IV according to the CTCAE v5.0, 2017); hypertension grade ≥ III (CTCAE v5.0, 2017); symptomatic intracranial hemorrhage resulting in transcient or permanent neurological deficit; any bleeding requiring transfusion; leukoencephalopathy grade ≥ III (CTCAE v5.0, 2017); Onset of intractable seizures ≥ Grade III (CTCAE v5.0, 2017); thrombo-embolic complication during the endovascular procedure leading to permanent deficit or to death; Intracranial arterial perforation with the microcatheter or the microguide wire during the endovascular procedure resulting in severe symptomatic hemorrhage (disability or death); any other serious adverse reaction (any untoward medical occurrence in a subject, to whom the medicinal product is administered, and which have a causal relationship with this treatment) resulting in any disability or death.
The secondary objectives and endpoints are to evaluate 1) the tolerance of 3 escalating doses of an in situ intra-arterial injection of bevacizumab in patients with a bAVM considered non-suitable for an exclusion treatment up to 12 months of follow-up; 2) To evaluate the efficacy of an in situ intra-arterial injection of bevacizumab in patients with a bAVM considered non-suitable for an exclusion treatment in terms of :Nidus volume size reduction at 6 and 12 months, Occurrence of cerebral bleeding events up to 12 months, Occurrence of seizures up to 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single in situ intra-arterial injection of bevacizumab | Experimental | Drug: Single in situ intra-arterial injection of bevacizumab3 Escalating doses of an in situ intra-arterial injection of Bevacizumab (5 mg/kg, 7.5 mg/kg, 10 mg/kg) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥18 and < 65 years at the time of inclusion
- bAVM (i.e.: located in the brain, brain stem or cerebellum)
- Spetzler-Martin grade IV - V on a brain MRI performed less than 2 months before inclusion
- History of rupture and/or with intractable symptoms related to the bAVM (i.e.: intractable seizure, steal phenomenon, compressive symptoms)
- bAVM deemed unsuitable for exclusion invasive treatment
Key exclusion criteria (25 listed)
- Diffuse bAVM (like proliferative angiopathy) that cannot be assessed in terms of volume by cross-sectional imaging on MRI
- Inability/contraindication to undergo MRI (Pacemaker, iron metallic items, cochlear implants, claustrophobia)
- Coagulation disorders (prothrombin time < 50% or Platelet count < 150 G/L)
- Any congenital predisposition to coagulation disorder
- Any disease requiring full anticoagulation
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 |
|---|---|---|
| Single in situ intra-arterial injection of bevacizumab3 Escalating doses of an in situ intra-arterial injection of Bevacizumab (5 mg/kg, 7.5 mg/kg, 10 mg/kg) | Drug | Single in situ intra-arterial injection of bevacizumab |
Primary outcome
Dose limiting toxicity
Time frame: Days 0 (day of the injection) to day 30
Dose limiting toxicity defined as the occurrence within 30 days of the in situ injection of bevacizumab of one of the following events: * Symptomatic venous/arterial thromboembolic events : pulmonary embolism, deep venous thrombosis, ischemic stroke, related to an arterial occlusion * Severe cytopenia defined as:Anemia defined as hemoglobin level less than 8.0 g/dL grade ≥ III,Thrombocytopenia < 50 G/L grade ≥ III * Neutropenia < 1000/μ L grade ≥ IV * Hypertension grade ≥ III * Symptomatic intracranial hemorrhage, resulting in transient/permanent neurological deficit * Any bleeding requiring transfusion * Leukoencephalopathy grade ≥ III * Onset of intractable seizures ≥ Grade III * Thrombo-embolic complication during the procedure leading to permanent deficit/death * Intracranial arterial perforation with the microcatheter/ microguide wire resulting in symptomatic hemorrhage causing any disability/death. * Any other serious adverse reaction resulting in any disability or death
4 secondary outcomes
Tolerance of escalating doses (3+3) of an in situ intra-arterial injection of bevacizumab
Time frame: Days 0 (day of the injection) to 12 months
Reduction of the nidus volume
Time frame: at 6 and 12 months
Occurrence of an intra-cerebral bleeding event
Time frame: Days 0 (day of the injection) to 12 months
Occurrence of at least one seizure
Time frame: Days 0 (day of the injection) to 12 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 20 Jul 2025.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Frédéric Clarençon, Professor principal investigator
Pitié-Salpêtrière Hospital, AP-HP - Neuroradiology department
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single in situ intra-arterial injection of bevacizumab in people with Brain Arteriovenous Malformations, run by Assistance Publique - Hôpitaux de Paris at 5 sites 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 15 inclusion and 25 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: opening soon, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Frédéric Clarençon, Professor ((+33)1 42 16 35 43, frederic.clarencon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (time frame: Days 0 (day of the injection) to day 30). 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 20 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.