HYPONCO - Hypoxia in Brain Tumors
Study Purpose
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).
- - 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.
- - Optimize radiotherapy treatment by identifying with accuracy, using 18F-FMISO PET, the most hypoxic areas which are also the most radio resistant.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT01200134 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
University Hospital, Caen |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
GUILLAMO Jean Sébastien, MD, PhDDERLON Jean Michel, MD, PhD |
| Principal Investigator Affiliation | University Hospital, CaenUniversity Hospital, Caen |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Completed |
| Countries | France |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Anaplastic Glioma |
Contact a Trial Team
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