Squamous Cell Carcinoma of the Head and NeckPhase 2NCT01774760
Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer
A Phase 2 study testing 18F-EF5 and Pretreatment PET/CT-scan (performed two times) in people with Squamous Cell Carcinoma of the Head and Neck, run by Turku University Hospital at 1 site in Finland.
Trial summary
The results of previous studies suggest further development of [18F]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- 18F-EF5 and Pretreatment PET/CT-scan (performed two times)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2013to Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
- Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck
- Primary tumor diameter as determined clinically or from contrast enhanced CT or T1-weighed MRI scan must be at least 15 mm
- Patients with nodal neck metastases of head and neck cancer are eligible
- Mental status: Patients must be able to understand the meaning of the study
- The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
- Patient, if female, must not be pregnant or lactating at the time of the study
Who cannot join
- Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease.
- Patient must have no history of previous chemotherapy or biological therapy or RT for treatment of head and neck cancer.
- Patient must not have an uncontrolled serious infection
- Patients with organ metastases in liver, bone, brain or lung.
Trial locations and contacts
1 site in 1 country.
About this study
The results of previous studies suggest further development of [18F]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans.
Read the detailed description
All patients will undergo normal diagnostic and staging procedures, including a conventional 18F-FDG PET/CT scan for the purpose of RT or surgical planning. In addition to that, an 18F-EF5 PET/CT scan will be performed on a separate day. The patients receive intravenous injection of 250-350 MBq of [18F]EF5. After that, a venous blood sample will be obtained for measurement of plasma radioactivity. A low-dose CT (helical) will be performed for attenuation correction and anatomical reference. After that, a PET scan will be performed (starting at 3 h after injection). The second 18F-EF5 scan will be performed in a similar way 4-7 days after the first scan. A representative histologic sample of primary tumor is pre-condition for study and an effort is made to store part of fresh histologic material in liquid nitrogen for later use in immunohistochemical analysis.
Patients are scheduled to undergo preoperative or definitive chemoradiotherapy using current clinical standards after completion of the current protocol. Follow-up information (event-free survival and overall survival) will be gathered.
- Being tested
- 18F-EF5, Pretreatment PET/CT-scan (performed two times)
- Keywords
- 18F-EF5, PET/CT, Reproducibility
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-EF5Drug
Also called PET/CT static imaging
Pretreatment PET/CT-scan (performed two times)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with stage III-IV head and neck cancer | Experimental | 18F-EF5 PET/CT scan Receives: Drug: 18F-EF5; Procedure: Pretreatment PET/CT-scan (performed two times) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV)
Standardized Uptake Values (SUV) are determined in the acquisition images of the [18F]EF5 studies.The difference between the baseline and second SUV is calculated and Bland-Altman plots are generated to compare the group means
Measured: Baseline and 7 days (ie time between the two scans)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heikki Minn, Turku University Hospital
- Investigators
- Heikki Minn, Professor, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774760
- Sponsor's protocol ID
- T14/2013
- Status last verified
- Sep 2019
- First submitted
- 21 Jan 2013
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01774760
- Acronym / sponsor ID
- T14/2013
- Keywords
- 18F-EF5, PET/CT, Reproducibility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Mar 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The results of previous studies suggest further development of [18F]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans.
Detailed description
All patients will undergo normal diagnostic and staging procedures, including a conventional 18F-FDG PET/CT scan for the purpose of RT or surgical planning. In addition to that, an 18F-EF5 PET/CT scan will be performed on a separate day. The patients receive intravenous injection of 250-350 MBq of [18F]EF5. After that, a venous blood sample will be obtained for measurement of plasma radioactivity. A low-dose CT (helical) will be performed for attenuation correction and anatomical reference. After that, a PET scan will be performed (starting at 3 h after injection). The second 18F-EF5 scan will be performed in a similar way 4-7 days after the first scan. A representative histologic sample of primary tumor is pre-condition for study and an effort is made to store part of fresh histologic material in liquid nitrogen for later use in immunohistochemical analysis.
Patients are scheduled to undergo preoperative or definitive chemoradiotherapy using current clinical standards after completion of the current protocol. Follow-up information (event-free survival and overall survival) will be gathered.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stage III-IV head and neck cancer | Experimental | Drug: 18F-EF5, Procedure: Pretreatment PET/CT-scan (performed two times)18F-EF5 PET/CT scan |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
- Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck
- Primary tumor diameter as determined clinically or from contrast enhanced CT or T1-weighed MRI scan must be at least 15 mm
- Patients with nodal neck metastases of head and neck cancer are eligible
- Mental status: Patients must be able to understand the meaning of the study
Key exclusion criteria (4 listed)
- Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease.
- Patient must have no history of previous chemotherapy or biological therapy or RT for treatment of head and neck cancer.
- Patient must not have an uncontrolled serious infection
- Patients with organ metastases in liver, bone, brain or lung.
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 |
|---|---|---|
| 18F-EF5Also: PET/CT static imaging | Drug | Patients with stage III-IV head and neck cancer |
| Pretreatment PET/CT-scan (performed two times) | Procedure or surgery | Patients with stage III-IV head and neck cancer |
Primary outcome
Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV)
Time frame: Baseline and 7 days (ie time between the two scans)
Standardized Uptake Values (SUV) are determined in the acquisition images of the [18F]EF5 studies.The difference between the baseline and second SUV is calculated and Bland-Altman plots are generated to compare the group means
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Heikki Minn, Professor principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-EF5 and Pretreatment PET/CT-scan (performed two times) in people with Squamous Cell Carcinoma of the Head and Neck, 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 7 inclusion and 4 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 4 Oct 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV) (time frame: Baseline and 7 days (ie time between the two scans)). 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 4 Oct 2019.