Prognostic Evaluation of 18fmiso Pet-ct in Head and Neck Cancer (MISORL)
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|ClinicalTrials.gov Identifier: NCT01235052|
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Head and Neck Head and Neck Neoplasms||Radiation: Positon Emission Tomography using 18F-FMISO||Not Applicable|
Hypoxia is one of the major worst prognostic factors of clinical outcome in cancer. It is actually admitted that hypoxia is heterogeneous, variable within different tumour types and that it varies spatially and temporally in a tumor. Hypoxia induce proteomic and gene expression changes that lead to increase angiogenesis, invasion and metastases. So, the hypoxic fraction in solid tumours reduces their sensitivity to conventional treatment modalities, modulating therapeutic response to ionizing radiation or certain chemotherapeutic agents. This is particularly important in head and neck cancers (HNC). Hypoxic cells in solid tumours could influence local failure following radiotherapy and has been associated with malignant progression, loco regional spread and distant metastases and represents an increasing probability of recurrence.
Thus, the non-invasive determination and monitoring of the oxygenation status could be of tumours is of importance to predict patient outcome and eventually modify therapeutic strategies in those tumours. Today, the oxygenation status of individual tumours is not assessed routinely. Numerous different approaches have been proposed to identify hypoxia in tumours. Eppendorf oxygen electrode measurements (pO2 histography) may be considered as a 'gold standard' for hypoxia in human malignancies. However, it is an invasive method being confined to superficial, well accessible tumours and requires many measures. PET using [18F]Fluoro-deoxyglucose (18F-FDG), allows non-invasive imaging of glucose metabolism and takes a growing place in cancer staging, But 18F-FDG can't assess correctly the oxygenation status of tumours. PET with appropriate radiotracers enables non-invasive assessment of presence and distribution of hypoxia in tumours. Nitroimidazoles are a class of electron affinic molecules that were shown to accumulate in hypoxic cells in vitro and in vivo. [18F]-FMISO is the most frequently used tracer ; its intracellular retention is dependent on oxygen tension. Consequently, [18F]-FMISO has been used as a non-invasive technique for detection of hypoxia in humans. Different authors have demonstrated that it is suitable to localize and quantify hypoxia. Thus, [18F]-FMISO PET has been studied to evaluate prognosis and predict treatment response. However, some investigators report an unclear correlation between Eppendorf measurements and standardized uptake values (SUV). This observation may be explained by the structural complexity of hypoxic tumour tissues. Nevertheless, there is a need of standardized procedures to acquire and quantify [18F]-FMISO uptake. Today, the use of this tracer is very limited in clinic and the academic studies have included small populations of patients and suffer of the heterogeneity of technical procedures.
The aim of this study is to determine the optimal acquisition protocol and image reconstruction to describe [18F]-FMISO uptake in HNC, then, to validate [18F]-FMISO-PET as a predictive marker of response to treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Prognostic Evaluation of Fluor 18 Labelled FLUROMISONIDAZOLE (18F-FMISO) Positon Emission Tomography-Computed Tomography (PET-CT) in Head and Neck Squamous Cell Carcinomas|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: TEP with 18F-FMISO
TEP with 18F-FMISO
Radiation: Positon Emission Tomography using 18F-FMISO
We will introduce a pretherapy [18F]-FMISO PET-CT in the treatment planning of patients suffering of head and neck cancer and eligible to a radical treatment with curative intent, consisting of conformational radiotherapy with or without chemotherapy or associated targeted therapy. [18F]-FMISO PET-CT results will not be taken into account for the patients' management. We will test different acquisition protocols and use a wild panel of quantification parameters issued from published studies and originals 'one developed by our team enable to describe [18F]-FMISO uptake. Patients will be followed clinically and para-clinically during two years after the end of the treatment according to the edited recommendations of these tumours type and grade to analyze outcome.
- Correlation between a hypoxic volume determined by [18F]-FMISO PET-CT and a treatment response two years after radical treatment. [ Time Frame: Inclusion (Day 0) and after two years ]
- Evaluate the potential role of a new biological tumour volume (BTV) taking account hypoxia for the delineation of volumes for radiotherapy treatment planning [ Time Frame: Inclusion (Day 0) ]
- Study pathological processes contributing to [18F]-FMISO uptake by the correlation with other parameters considered to be representative of hypoxia in tumours [ Time Frame: After two years ]
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): NCT01235052
|CHU de Bordeaux - Hôpital Pellegrin|
|Bordeaux, France, 33 076|
|Hôpital Robert Picqué|
|Villenave D Ornon, France, 33882|
|Principal Investigator:||CLERMONT-GALLERANDE Henri, MCU-PH||University Hospital, Bordeaux|
|Study Chair:||PEREZ Paul, PH||University Hospital, Bordeaux|