Head and Neck CancerEF5NECKNCT05246475
Measurement of Head and Neck Tumor Hypoxia With PET-MRI
A study testing PET-MRI in people with Head and Neck Cancer, run by Turku University Hospital at 1 site in Finland.
Trial summary
This study is designed to evaluate the performance of advanced magnetic resonance (MR) imaging in the assessment of tumor hypoxia using [18F]EF5 positron emission tomography (PET) as a reference in head and neck cancer patients. Low oxygen level or hypoxia contributes to radiotherapy resistance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- PET-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 8 Feb 2022to Oct 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 80 years old
- Sex: male or female
- Language spoken: Finnish or Swedish
- Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
- Mental status: Patients must be able to understand the meaning of the study
- Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck (oral cavity, pharynx or larynx)
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- Primary tumor diameter as determined clinically or from contrast enhanced CT or MRI scan must be at least 20 mm
- Patients with nodal neck metastases of head and neck cancer are eligible
- Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
- Gravidity: Patient, if female, must not be pregnant or lactating at the time of the study
Who cannot join
- Any previously known contraindication of MR Imaging (including but not limited to metallic implants or foreign bodies, pacemakers or other cardiac implantable electronic devices, MR-incompatible prosthetic heart valves, contrast allergy, claustrophobia)
- Prior Medical History: Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease. Since none of these is an absolute contraindication for inclusion final judgement will be left to the investigators.
- Prior Therapy: Patient must have no history of previous chemotherapy, biological therapy, immunotherapy, radiotherapy or major surgery for treatment of head and neck cancer
- Infections: Patient must not have an uncontrolled serious infection
- Advanced disease: Patient is not eligible for curative cancer treatment due to advanced disease.
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, G102881, 20521
Jussi Hirvonen, MD, PhD, 0035823130000, jussi.hirvonen@tyks.fi
Antti Silvoniemi, MD, PhD, 0035823130000, antti.silvoniemi@tyks.fi
About this study
Official title: Simultaneous PET-MRI for Comparison of Advanced DW-MRI Techniques and EF5-PET in the Detection of Hypoxia in Head and Neck Cancer
This study is designed to evaluate the performance of advanced magnetic resonance (MR) imaging in the assessment of tumor hypoxia using [18F]EF5 positron emission tomography (PET) as a reference in head and neck cancer patients. Low oxygen level or hypoxia contributes to radiotherapy resistance. Therefore, a clinically applicable method to detect tumor hypoxia is of great importance.
Read the detailed description
This is a non-randomized prospective study which aims to compare [18F]EF5 PET data and MR imaging data acquired with simultaneous PET/MR imaging. Hypoxic tumor tends to be more aggressive than its non-hypoxic counterpart since hypoxia promotes invasive tumor growth and metastatic spread of the disease. The detrimental effect of hypoxia on outcome of radiotherapy (RT) is especially important in head and neck cancer.
EF5 is a comprehensively studied hypoxia-avid compound, which is utilized in radiolabeled form in [18F]EF5 PET imaging detecting tumor hypoxia. IVIM (intra-voxel incoherent motion) is novel technique based on diffusion-weighted MRI (DWI), which allows for the distinction between tissue perfusion and diffusion without the need for intravenous contrast agent. This study aims to investigate the potential of novel MRI techniques for tumor hypoxia assessment in HNC.
The specific aims of the current study are:
- To characterize the voxel-level relationship between diffusion characteristics in tumor tissue, as measured with DW-MRI, and tumor hypoxia, as measured with [18F]EF5-PET, leveraging the state-of-the-art simultaneous MRI/PET measurement;
- To employ IVIM-based modeling of DW-MRI signal using multiple b-values to optimize the diffusion metrics that most closely predict tumor hypoxia, and compare those with the perfusion metrics from DCE;
- To develop models based on novel radiophenotypic analyses of MRI data (radiomics) and machine learning algorithms to find MRI patterns that best predict tumor hypoxia at the patient sample level.
The only intervention for participating subjects is an additional [18F]EF5-PET/MR scan, which is not used for any clinical purposes. All study subjects will undergo standard diagnostic and treatment procedures according to clinical routine.
A standard dose of about 300 MBq of the radiotracer [18F]EF5 will be administered intravenously via an upper extremity vein. About 180 min after tracer injection, radioactivity will be followed in the neck area with the PET/MRI device for about 20 min. [18F]EF5 uptake will be modeled as standard uptake value (SUV), and tumor-to-background ratios (TBR) will be calculated.
The MRI protocol will include anatomical sequences covering the primary tumor as well as the neck for lymph node metastases. Several DW-MRI methods will also be employed. In total, MRI experiments will be completed in about 1 hour.
- Conditions
- Head and Neck Cancer
- Being tested
- PET-MRI
- 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.
PET-MRIDiagnostic test
Simultaneous PET-MRI measurement
| Study group | Role | What they receive |
|---|---|---|
| PET-MRI | Experimental | Simultaneous 18F-EF5 PET and DW-MRI Receives: Diagnostic Test: PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET-MRI correlation
Voxel level correlation of DW-MRI and PET estimates
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start8 Feb 2022
- Primary completionMay 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will be scanned with both MRI and PET.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jussi Hirvonen, Turku University Hospital
- Investigators
- Jussi Hirvonen, MD, PhD, Principal investigator, Radiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246475
- Sponsor's protocol ID
- T255/2021
- Acronym
- EF5NECK
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous PET-MRI for Comparison of Advanced DW-MRI Techniques and EF5-PET in the Detection of Hypoxia in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05246475
- Acronym / sponsor ID
- EF5NECK / T255/2021
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Feb 2022 (actual)
- 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.
This study is designed to evaluate the performance of advanced magnetic resonance (MR) imaging in the assessment of tumor hypoxia using [18F]EF5 positron emission tomography (PET) as a reference in head and neck cancer patients. Low oxygen level or hypoxia contributes to radiotherapy resistance. Therefore, a clinically applicable method to detect tumor hypoxia is of great importance.
Detailed description
This is a non-randomized prospective study which aims to compare [18F]EF5 PET data and MR imaging data acquired with simultaneous PET/MR imaging. Hypoxic tumor tends to be more aggressive than its non-hypoxic counterpart since hypoxia promotes invasive tumor growth and metastatic spread of the disease. The detrimental effect of hypoxia on outcome of radiotherapy (RT) is especially important in head and neck cancer.
EF5 is a comprehensively studied hypoxia-avid compound, which is utilized in radiolabeled form in [18F]EF5 PET imaging detecting tumor hypoxia. IVIM (intra-voxel incoherent motion) is novel technique based on diffusion-weighted MRI (DWI), which allows for the distinction between tissue perfusion and diffusion without the need for intravenous contrast agent. This study aims to investigate the potential of novel MRI techniques for tumor hypoxia assessment in HNC.
The specific aims of the current study are:
- To characterize the voxel-level relationship between diffusion characteristics in tumor tissue, as measured with DW-MRI, and tumor hypoxia, as measured with [18F]EF5-PET, leveraging the state-of-the-art simultaneous MRI/PET measurement;
- To employ IVIM-based modeling of DW-MRI signal using multiple b-values to optimize the diffusion metrics that most closely predict tumor hypoxia, and compare those with the perfusion metrics from DCE;
- To develop models based on novel radiophenotypic analyses of MRI data (radiomics) and machine learning algorithms to find MRI patterns that best predict tumor hypoxia at the patient sample level.
The only intervention for participating subjects is an additional [18F]EF5-PET/MR scan, which is not used for any clinical purposes. All study subjects will undergo standard diagnostic and treatment procedures according to clinical routine.
A standard dose of about 300 MBq of the radiotracer [18F]EF5 will be administered intravenously via an upper extremity vein. About 180 min after tracer injection, radioactivity will be followed in the neck area with the PET/MRI device for about 20 min. [18F]EF5 uptake will be modeled as standard uptake value (SUV), and tumor-to-background ratios (TBR) will be calculated.
The MRI protocol will include anatomical sequences covering the primary tumor as well as the neck for lymph node metastases. Several DW-MRI methods will also be employed. In total, MRI experiments will be completed in about 1 hour.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will be scanned with both MRI and PET.
| Arm | Type | Receives |
|---|---|---|
| PET-MRI | Experimental | Diagnostic Test: PET-MRISimultaneous 18F-EF5 PET and DW-MRI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18 to 80 years old
- Sex: male or female
- Language spoken: Finnish or Swedish
- Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
- Mental status: Patients must be able to understand the meaning of the study
Key exclusion criteria (5 listed)
- Any previously known contraindication of MR Imaging (including but not limited to metallic implants or foreign bodies, pacemakers or other cardiac implantable electronic devices, MR-incompatible prosthetic heart valves, contrast allergy, claustrophobia)
- Prior Medical History: Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease. Since none of these is an absolute contraindication for inclusion final judgement will be left to the investigators.
- Prior Therapy: Patient must have no history of previous chemotherapy, biological therapy, immunotherapy, radiotherapy or major surgery for treatment of head and neck cancer
- Infections: Patient must not have an uncontrolled serious infection
- Advanced disease: Patient is not eligible for curative cancer treatment due to advanced disease.
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 |
|---|---|---|
| PET-MRISimultaneous PET-MRI measurement | Diagnostic test | PET-MRI |
Primary outcome
PET-MRI correlation
Time frame: 1 day
Voxel level correlation of DW-MRI and PET estimates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Jussi Hirvonen, MD, PhD principal investigator
Radiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-MRI in people with Head and Neck Cancer, run by Turku University Hospital at 1 site in Finland.
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 10 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Feb 2022. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jussi Hirvonen, MD, PhD (0035823130000, jussi.hirvonen@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET-MRI correlation (time frame: 1 day). 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 18 Feb 2022.