Anaplastic GliomaPhase 2HYPONCONCT01200134
HYPONCO - Hypoxia in Brain Tumors
A Phase 2 study testing 18F-FMISO PET-scanning in people with Anaplastic Glioma, run by University Hospital, Caen at 1 site in France.
Trial summary
Background : In malignant gliomas, hypoxia is associated with tumour angiogenesis and tumour progression. This multidisciplinary preclinical and clinical project aims to validate the use of 18F-FMISO as a hypoxic marker for diagnosis, treatment and follow-up of malignant gliomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Glioma
- What is being tested?
- 18F-FMISO PET-scanning
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- adults aged >= 18 years
- KPS >= 70%
- must have the understanding and ability to sign an informed consent document
- be male or non-pregnant
- non-lactating females
- Patients who are fertile must agree to use an effective method of contraception during participation in the study
- the following laboratory results : absolute neutrophil count >= 1500 cells/µl, platelet count >= 100,000 cells/µl, SGOT <= 2.5 x ULN, serum creatinine <= 1.5 x ULN
Who cannot join
- contraindication to surgery
- concomitant radio-, chemo-, or immunotherapy
- known diagnosis of Human Immunodeficiency Virus (HIV) infection
- patient with hepatitis B or C
- diabetic patient
- patient with kidney or liver deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypoxia Diagnosis and Evaluation Using F-MISO PET and Biomarkers in Brain Tumors
Background :
In malignant gliomas, hypoxia is associated with tumour angiogenesis and tumour progression. This multidisciplinary preclinical and clinical project aims to validate the use of 18F-FMISO as a hypoxic marker for diagnosis, treatment and follow-up of malignant gliomas. Indeed, non-invasive methods of imagery such as Positron Emission Tomography (PET) and biological methods (after surgical resection) to detect the endogenous expression of factors induced by the hypoxia would allow to identify hypoxic areas. Identifying, with accuracy, the hypoxic areas could allow the clinicians to evaluate the response to the anti-angiogenic agents (preliminary validation in the preclinical project) and to optimize the combination of the anti-VEGF treatments with other conventional therapeutic approaches (radiotherapy, chemotherapy or other molecules).
Read more
Research project :
This research project includes 3 steps : first the investigators will establish the 18F-FMISO production technique for clinical application at CYCERON PET center. The second step consists in the preclinical validation of 18F-FMISO as a hypoxic marker and as a powerful tool for evaluating the therapeutical efficiency of anti-angiogenic treatment (sutent) in experimental rat gliomas. The third step is the clinical trial HypOnco. This research proposal aims to develop and use non invasive imaging methods (18F-FMISO with PET) and biological methods (after surgical resection) to detect hypoxic (HIF1 and HIF2) and angiogenic (VEGF and EPO) regions in different malignant gliomas with different degrees of vascularization (15 patients with grade III gliomas and 15 patients with grade IV glioblastomas). Within the same patient 18F-FMISO as a hypoxic index will be performed. A magnetic resonance imaging examination (MRI) including perfusion sequences and MR spectroscopy will also be assessed for each patient. Following this imaging protocol, surgical resection will be performed allowing us to study expression of endogenous factors induced by hypoxia and angiogenic factors by real time RT-PCR and in immunohistochemistry.
The data obtained will enable us to establish :
- a hypoxic index (18F-FMISO with PET).
- an index of hypoxic factor expression (HIFs)
- an angiogenic index (VEGF, EPO, vascular markers)
The investigators will characterize the links between these data and also with the following parameters:
- clinical (age, Karnofsky performance status, survival)
- MR parameters included perfusion and spectroscopy
- histological (necrosis, cellular proliferation, atypical cell abnormalities, vascularization).
Expected results and clinical advantages
- To establish the 18F-FMISO production technique
- To propose the 18F-FMISO as a non-invasive marker for efficacy of antiangiogenic treatment in a preclinical study.
- To define the relationship between the 18F-FMISO uptake and tumour grade, patient survival, tumour recurrence, expression of hypoxic and angiogenic factors and tumour vascularisation.
- To provide a hypoxic index in cerebral tumours from 18F-FMISO PET, allowing diagnosis and prognosis improvement for optimal treatment orientation and strategy.
In the field of the clinical applications, this tool will allow to :
- Optimize radiotherapy treatment by identifying with accuracy, using 18F-FMISO PET, the most hypoxic areas which are also the most radio resistant.
- Evaluate antiangiogenic therapy efficacy
- Conditions
- Anaplastic Glioma
- Being tested
- 18F-FMISO PET-scanning
- Keywords
- glioma patients : anaplasic glioma (grade III) and GBM (grade IV)
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FMISO PET-scanningOther
Other: 18F-FMISO PET-scanning 18F-FMISO PET-scanning: 18F-FMISO PET-scanning will be performed at the same place following the same protocol as mentioned above. However, the 20-minutes period of PET images acquisition will start 120 minutes after the 18F-FMISO bolus injection (0.05 mCi/kg).
| Study group | Role | What they receive |
|---|---|---|
| 18F-FMISO PET-scanning | Experimental | Other: 18F-FMISO PET-scanning 18F-FMISO PET-scanning: 18F-FMISO PET-scanning will be performed at the same place following the same protocol as mentioned above. However, the 20-minutes period of PET images acquisition will start 120 minutes after the 18F-FMISO bolus injection (0.05 mCi/kg). Receives: Other: 18F-FMISO PET-scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoxia volume (HV) and degree (maximum ratio [Rmax]) defined from 18F-FMISO uptake rates
- determine, in vivo, the hypoxic character of tumours from a PET biomarker. Tumoral hypoxia will be characterized by hypoxia volume (HV) and degree (maximum ratio [Rmax]) defined from 18F-FMISO uptake rates
- characterize the link between the tumoral hypoxia and the hypoxic and angiogenic factor expressions that favour vascular neoformation and proliferation feeding tumoral cells
Measured: PET 18F-MISO between Day 1 & Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic GliomaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GUILLAMO Jean Sébastien, MD, PhD, Principal investigator, University Hospital, CaenDERLON Jean Michel, MD, PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200134
- Sponsor's protocol ID
- 2009-015543-16
- Other IDs
- 2009
- Acronym
- HYPONCO
- Status last verified
- Nov 2012
- First submitted
- 10 Sep 2010
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia Diagnosis and Evaluation Using F-MISO PET and Biomarkers in Brain Tumors
- ClinicalTrials.gov ID
- NCT01200134
- Acronym / sponsor ID
- HYPONCO / 2009-015543-16
- Conditions
- Anaplastic Glioma
- Keywords
- glioma patients : anaplasic glioma (grade III) and GBM (grade IV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Sep 2010 (estimated)
- 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.
Background :
In malignant gliomas, hypoxia is associated with tumour angiogenesis and tumour progression. This multidisciplinary preclinical and clinical project aims to validate the use of 18F-FMISO as a hypoxic marker for diagnosis, treatment and follow-up of malignant gliomas. Indeed, non-invasive methods of imagery such as Positron Emission Tomography (PET) and biological methods (after surgical resection) to detect the endogenous expression of factors induced by the hypoxia would allow to identify hypoxic areas. Identifying, with accuracy, the hypoxic areas could allow the clinicians to evaluate the response to the anti-angiogenic agents (preliminary validation in the preclinical project) and to optimize the combination of the anti-VEGF treatments with other conventional therapeutic approaches (radiotherapy, chemotherapy or other molecules).
Research project :
This research project includes 3 steps : first the investigators will establish the 18F-FMISO production technique for clinical application at CYCERON PET center. The second step consists in the preclinical validation of 18F-FMISO as a hypoxic marker and as a powerful tool for evaluating the therapeutical efficiency of anti-angiogenic treatment (sutent) in experimental rat gliomas. The third step is the clinical trial HypOnco. This research proposal aims to develop and use non invasive imaging methods (18F-FMISO with PET) and biological methods (after surgical resection) to detect hypoxic (HIF1 and HIF2) and angiogenic (VEGF and EPO) regions in different malignant gliomas with different degrees of vascularization (15 patients with grade III gliomas and 15 patients with grade IV glioblastomas). Within the same patient 18F-FMISO as a hypoxic index will be performed. A magnetic resonance imaging examination (MRI) including perfusion sequences and MR spectroscopy will also be assessed for each patient. Following this imaging protocol, surgical resection will be performed allowing us to study expression of endogenous factors induced by hypoxia and angiogenic factors by real time RT-PCR and in immunohistochemistry.
The data obtained will enable us to establish :
- a hypoxic index (18F-FMISO with PET).
- an index of hypoxic factor expression (HIFs)
- an angiogenic index (VEGF, EPO, vascular markers)
The investigators will characterize the links between these data and also with the following parameters:
- clinical (age, Karnofsky performance status, survival)
- MR parameters included perfusion and spectroscopy
- histological (necrosis, cellular proliferation, atypical cell abnormalities, vascularization).
Expected results and clinical advantages
- To establish the 18F-FMISO production technique
- To propose the 18F-FMISO as a non-invasive marker for efficacy of antiangiogenic treatment in a preclinical study.
- To define the relationship between the 18F-FMISO uptake and tumour grade, patient survival, tumour recurrence, expression of hypoxic and angiogenic factors and tumour vascularisation.
- To provide a hypoxic index in cerebral tumours from 18F-FMISO PET, allowing diagnosis and prognosis improvement for optimal treatment orientation and strategy.
In the field of the clinical applications, this tool will allow to :
- Optimize radiotherapy treatment by identifying with accuracy, using 18F-FMISO PET, the most hypoxic areas which are also the most radio resistant.
- Evaluate antiangiogenic therapy efficacy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FMISO PET-scanning | Experimental | Other: 18F-FMISO PET-scanningOther: 18F-FMISO PET-scanning 18F-FMISO PET-scanning: 18F-FMISO PET-scanning will be performed at the same place following the same protocol as mentioned above. However, the 20-minutes period of PET images acquisition will start 120 minutes after the 18F-FMISO bolus injection (0.05 mCi/kg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adults aged >= 18 years
- KPS >= 70%
- must have the understanding and ability to sign an informed consent document
- be male or non-pregnant
- non-lactating females
Key exclusion criteria (6 listed)
- contraindication to surgery
- concomitant radio-, chemo-, or immunotherapy
- known diagnosis of Human Immunodeficiency Virus (HIV) infection
- patient with hepatitis B or C
- diabetic patient
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 |
|---|---|---|
| 18F-FMISO PET-scanningOther: 18F-FMISO PET-scanning 18F-FMISO PET-scanning: 18F-FMISO PET-scanning will be performed at the same place following the same protocol as mentioned above. However, the 20-minutes period of PET images acquisition will start 120 minutes after the 18F-FMISO bolus injection (0.05 mCi/kg). | Other | 18F-FMISO PET-scanning |
Primary outcome
hypoxia volume (HV) and degree (maximum ratio [Rmax]) defined from 18F-FMISO uptake rates
Time frame: PET 18F-MISO between Day 1 & Day 7
* determine, in vivo, the hypoxic character of tumours from a PET biomarker. Tumoral hypoxia will be characterized by hypoxia volume (HV) and degree (maximum ratio [Rmax]) defined from 18F-FMISO uptake rates * characterize the link between the tumoral hypoxia and the hypoxic and angiogenic factor expressions that favour vascular neoformation and proliferation feeding tumoral cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
Related trials for Anaplastic Glioma
Active, not recruitingPhase 2
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma
Anaplastic Astrocytoma, Anaplastic Astrocytoma, Not Otherwise Specified
RecruitingPhase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Central Nervous System Neoplasms, Glioblastoma
Active, not recruitingPhase 1
Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma
Recurrent Glioblastoma, Recurrent Malignant Glioma
RecruitingEarly Phase 1
Implantable Microdevice In Primary Brain Tumors
Grade II Glioma, Grade III Glioma
Active, not recruitingPhase 2
Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations
Anaplastic Astrocytoma, Glioblastoma
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. This study is not recruiting at the moment.
GUILLAMO Jean Sébastien, MD, PhD principal investigator
University Hospital, Caen
DERLON Jean Michel, MD, PhD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-FMISO PET-scanning in people with Anaplastic Glioma, run by University Hospital, Caen 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 19 Nov 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypoxia volume (HV) and degree (maximum ratio [Rmax]) defined from 18F-FMISO uptake rates (time frame: PET 18F-MISO between Day 1 & Day 7). 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 19 Nov 2012.