Cancer of Head and NeckMISORLNCT01235052
Prognostic Evaluation of 18fmiso Pet-ct in Head and Neck Cancer
A study testing Positon Emission Tomography using 18F-FMISO in people with Cancer of Head and Neck and Head and Neck Neoplasms, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
Head and neck cancer is the sixth most frequent cancer worldwide, excluding lymphomas and skin cancer. If 18FDG PET is considered today as a standard tool in patients with head and neck squamous cell carcinoma (HNSCC) not only for tumoral or nodal staging but also for assessment of distant metastases and synchronous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck, Head and Neck Neoplasms
- What is being tested?
- Positon Emission Tomography using 18F-FMISO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2009to Jul 2014
- Phase
- Interventional
- 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
- Patients over 18
- Patients presenting a squamous cell head and neck carcinoma proposed for a radical treatment consisting in conformational radiotherapy with or without chemotherapy or associated targeted therapy
- Signed informed consent
Who cannot join
- Patients with distant metastases known before inclusion
- Patients suffering of a second cancer or treated before by radiotherapy in the tumour site.
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33 076
Hôpital Robert Picqué
Villenave-d'Ornon, 33882
About this study
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
Head and neck cancer is the sixth most frequent cancer worldwide, excluding lymphomas and skin cancer. If 18FDG PET is considered today as a standard tool in patients with head and neck squamous cell carcinoma (HNSCC) not only for tumoral or nodal staging but also for assessment of distant metastases and synchronous second primary malignancies, hypoxia is one of the most important prognostic factors in radiotherapy of this type of tumors. The only gold standard method for direct determination of oxygen tension is based on using oxygen electrodes showing a good relation with clinical outcome but complex in its realisation. So, PET using 18F-FMISO has been described to be useful for the non invasive assessment of hypoxia in cancer. Especially in France, the use of this radiotracer is very limited and there is no standardised methodology to acquire and quantify 18F-FMISO signal. So there is a need for a rigorous evaluation of this PET tracer. In another way, it could be a very useful tool for evaluation of new therapies and modification of volumes in radiotherapy.
Read the detailed description
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.
- Conditions
- Cancer of Head and Neck, Head and Neck Neoplasms
- Being tested
- Positon Emission Tomography using 18F-FMISO
- Keywords
- Head and neck neoplasms, Positron Emission Tomography, F18 fluoromisonidazole
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positon Emission Tomography using 18F-FMISORadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| TEP with 18F-FMISO | Experimental | TEP with 18F-FMISO Receives: Radiation: Positon Emission Tomography using 18F-FMISO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between a hypoxic volume determined by [18F]-FMISO PET-CT and a treatment response two years after radical treatment.
Measured: Inclusion (Day 0) and after two years
Secondary outcomes (2)
Evaluate the potential role of a new biological tumour volume (BTV) taking account hypoxia for the delineation of volumes for radiotherapy treatment planning
Measured: 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
Measured: After two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startJun 2009
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CLERMONT-GALLERANDE Henri, MCU-PH, Principal investigator, University Hospital, BordeauxPEREZ Paul, PH, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235052
- Sponsor's protocol ID
- CHUBX 2008/20
- Other IDs
- 2008-006411-20, 2008
- Acronym
- MISORL
- Status last verified
- Aug 2014
- First submitted
- 28 Oct 2009
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Henriques de Figueiredo B, Zacharatou C, Galland-Girodet S, Benech J, De Clermont-Gallerande H, Lamare F, Hatt M, Digue L, De Mones del Pujol E, Fernandez P. Hypoxia imaging with [18F]-FMISO-PET for guided dose escalation with intensity-modulated radiotherapy in head-and-neck cancers. Strahlenther Onkol. 2015 Mar;191(3):217-24. doi: 10.1007/s00066-014-0752-8. Epub 2014 Sep 23.
PubMed 25245468Henriques de Figueiredo B, Merlin T, de Clermont-Gallerande H, Hatt M, Vimont D, Fernandez P, Lamare F. Potential of [18F]-fluoromisonidazole positron-emission tomography for radiotherapy planning in head and neck squamous cell carcinomas. Strahlenther Onkol. 2013 Dec;189(12):1015-9. doi: 10.1007/s00066-013-0454-7. Epub 2013 Nov 1.
PubMed 24173497
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01235052
- Acronym / sponsor ID
- MISORL / CHUBX 2008/20
- Conditions
- Cancer of Head and Neck, Head and Neck Neoplasms
- Keywords
- Head and neck neoplasms, Positron Emission Tomography, F18 fluoromisonidazole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Nov 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.
Head and neck cancer is the sixth most frequent cancer worldwide, excluding lymphomas and skin cancer. If 18FDG PET is considered today as a standard tool in patients with head and neck squamous cell carcinoma (HNSCC) not only for tumoral or nodal staging but also for assessment of distant metastases and synchronous second primary malignancies, hypoxia is one of the most important prognostic factors in radiotherapy of this type of tumors. The only gold standard method for direct determination of oxygen tension is based on using oxygen electrodes showing a good relation with clinical outcome but complex in its realisation. So, PET using 18F-FMISO has been described to be useful for the non invasive assessment of hypoxia in cancer. Especially in France, the use of this radiotracer is very limited and there is no standardised methodology to acquire and quantify 18F-FMISO signal. So there is a need for a rigorous evaluation of this PET tracer. In another way, it could be a very useful tool for evaluation of new therapies and modification of volumes in radiotherapy.
Detailed description
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEP with 18F-FMISO | Experimental | Radiation: Positon Emission Tomography using 18F-FMISOTEP with 18F-FMISO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18
- Patients presenting a squamous cell head and neck carcinoma proposed for a radical treatment consisting in conformational radiotherapy with or without chemotherapy or associated targeted therapy
- Signed informed consent
Key exclusion criteria (3 listed)
- Patients with distant metastases known before inclusion
- Patients suffering of a second cancer or treated before by radiotherapy in the tumour site.
- Pregnancy
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 |
|---|---|---|
| Positon Emission Tomography using 18F-FMISOWe 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. | Radiation | TEP with 18F-FMISO |
Primary 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
2 secondary outcomes
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
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 14 May 2026.
- Results publication: PubMed 25245468Henriques de Figueiredo B, Zacharatou C, Galland-Girodet S, Benech J, De Clermont-Gallerande H, Lamare F, Hatt M, Digue L, De Mones del Pujol E, Fernandez P. Hypoxia imaging with [18F]-FMISO-PET for guided dose escalation with intensity-modulated radiotherapy in head-and-neck cancers. Strahlenther Onkol. 2015 Mar;191(3):217-24. doi: 10.1007/s00066-014-0752-8. Epub 2014 Sep 23.
- Results publication: PubMed 24173497Henriques de Figueiredo B, Merlin T, de Clermont-Gallerande H, Hatt M, Vimont D, Fernandez P, Lamare F. Potential of [18F]-fluoromisonidazole positron-emission tomography for radiotherapy planning in head and neck squamous cell carcinomas. Strahlenther Onkol. 2013 Dec;189(12):1015-9. doi: 10.1007/s00066-013-0454-7. Epub 2013 Nov 1.
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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. This study is not recruiting at the moment.
CLERMONT-GALLERANDE Henri, MCU-PH principal investigator
University Hospital, Bordeaux
PEREZ Paul, PH study chair
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positon Emission Tomography using 18F-FMISO in people with Cancer of Head and Neck and Head and Neck Neoplasms, run by University Hospital, Bordeaux at 2 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 3 inclusion and 3 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01235052, which also lists 2 linked publications.
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 14 May 2026.