HYPONCO - Hypoxia in Brain Tumors (HYPONCO)
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ClinicalTrials.gov Identifier: NCT01200134 |
Recruitment Status
:
Completed
First Posted
: September 13, 2010
Last Update Posted
: November 19, 2012
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anaplastic Glioma | Other: 18F-FMISO PET-scanning | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Hypoxia Diagnosis and Evaluation Using F-MISO PET and Biomarkers in Brain Tumors |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | July 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: 18F-FMISO PET-scanning
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).
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Other: 18F-FMISO PET-scanning
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).
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- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200134
France | |
Caen University Hospital | |
Caen, France, 14033 |
Principal Investigator: | GUILLAMO Jean Sébastien, MD, PhD | University Hospital, Caen | |
Principal Investigator: | DERLON Jean Michel, MD, PhD | University Hospital, Caen |
Responsible Party: | University Hospital, Caen |
ClinicalTrials.gov Identifier: | NCT01200134 History of Changes |
Other Study ID Numbers: |
2009-015543-16 |
First Posted: | September 13, 2010 Key Record Dates |
Last Update Posted: | November 19, 2012 |
Last Verified: | November 2012 |
Keywords provided by University Hospital, Caen:
glioma patients : anaplasic glioma (grade III) and GBM (grade IV) |
Additional relevant MeSH terms:
Brain Neoplasms Hypoxia Brain Diseases Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms |
Nervous System Neoplasms Neoplasms by Site Central Nervous System Diseases Nervous System Diseases Signs and Symptoms, Respiratory Signs and Symptoms Misonidazole Antineoplastic Agents Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |