Head and Neck Squamous Cell CarcinomaHENEPETNCT04196985
18F-FDG PET/CT Versus 18F-FDG PET/MRI in Detecting Locoregional Recurrence 3 Months After CRT in Head and Neck SCC
A study testing PET/MRI and PET/CT in people with Head and Neck Squamous Cell Carcinoma, run by Turku University Hospital at 1 site in Finland.
Trial summary
Comparing FDG PET/CT and FDG PET/MRI in the diagnostic accuracy of detecting local recurrence 12 weeks after the end of CRT in head and neck squamous cell carcinoma patients. Forty patients aged more than 18 years who have a histologically confirmed HNSCC and have received chemoradiation therapy will be recruited for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- PET/MRI and PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 1 Oct 2020to 1 Oct 2024
- 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
- Age 18 years or older
- Language spoken: Finnish or Swedish
- Diagnosis: Histologically confirmed HNSCC
- Chemoradiotherapy treatment with curative intent to the primary tumor and/or neck LN metastasis that has ended 12+- 4 weeks before the PET scan.
- Clinical stage: Stage I-II at least 20 patients, Stage III-IV at least 20 patients
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient has to have signed the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
Who cannot join
- Uncontrolled serious infection
- Contraindications for MRI (cardiac pacemaker, intracranial clips etc., allergic reaction to contrast agent)
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country.
Simona Malaspina, MD contact
Finland1 site, 1 recruiting
- Recruiting
Turku PET Centre
Turku
Simona Malaspina, MD, simona.malaspina@tyks.fi
About this study
Official title: Comparison Between 18F-FDG PET/CT and 18F-FDG PET/MRI in Detecting Locoregional Recurrence 3 Months After Chemoradiation Therapy (CRT) in Head and Neck Squamous Cell Carcinoma (SCC)
Comparing FDG PET/CT and FDG PET/MRI in the diagnostic accuracy of detecting local recurrence 12 weeks after the end of CRT in head and neck squamous cell carcinoma patients. Forty patients aged more than 18 years who have a histologically confirmed HNSCC and have received chemoradiation therapy will be recruited for the study. The patients will be scanned with both PET/CT and PET/MRI 12 weeks after the end of CRT.
Read the detailed description
Since recurrence of HNSCC occurs in up to 50 percent of cases in the first two years following treatments and the recurrent diseases are less responsive to new treatments, detecting local/regional recurrence at an earlier time is crucial in order to provide salvage treatments. The primary objective of this prospective study is to compare the diagnostic accuracy of FDG PET/CT to FDG PET/MRI in the detection of local recurrence 12 weeks after the end of chemoradiation treatment in HNSCC patients. The hypothesis is that PET/MRI might be able to diagnose locoregional recurrence earlier and more accurately which would lead to a better outcome for the patient. If it is proven correct, it would be possible to optimize the use of PET/MRI imaging on selected patients who are likely to benefit clearly from the use of that modality.
Forty patients aged more than 18 years who have a histologically confirmed HNSCC and have received chemoradiation therapy will be recruited for the study. The patients will be scanned with both FDG-PET/CT and FDG-PET/MRI 12 weeks after the end of CRT.
All study participants will be consented, and the estimated time for completing the PET scans of 40 patients will take 12 to 15 months. The results will be reported in international peer-reviewed high-impact journals.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- PET/MRI, PET/CT
- Keywords
- PET-imaging, local recurrence, PET/MRI, chemoradiotherapy
- 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.
PET/MRIDiagnostic test
each patient will perform PET/CT and PET/MRI scans in two different days within the interval of less than 2 weeks receiving two different FDG injections. Administered FDG activity for each PET scan will be 4 MBq/Kg up to a maximum of 400 MBq.
PET/CTDiagnostic test
each patient will perform PET/CT and PET/MRI scans in two different days within the interval of less than 2 weeks receiving two different FDG injections. Administered FDG activity for each PET scan will be 4 MBq/Kg up to a maximum of 400 MBq.
| Study group | Role | What they receive |
|---|---|---|
| Patients with HNSCC | Experimental | Patients who have histologically confirmed HNSCC and have received CRT for it Receives: Diagnostic Test: PET/MRI; Diagnostic Test: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence
local recurrence detected with PET/TT vs. with PET/MRI
Measured: 12 weeks after chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Oct 2020
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2024 (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 Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jukka Kemppainen, MD PhD, Principal investigator, Turku University Hospital PET Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196985
- Sponsor's protocol ID
- HENEPET
- Acronym
- HENEPET
- Status last verified
- Apr 2021
- First submitted
- 20 Nov 2019
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between 18F-FDG PET/CT and 18F-FDG PET/MRI in Detecting Locoregional Recurrence 3 Months After Chemoradiation Therapy (CRT) in Head and Neck Squamous Cell Carcinoma (SCC)
- ClinicalTrials.gov ID
- NCT04196985
- Acronym / sponsor ID
- HENEPET / HENEPET
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- PET-imaging, local recurrence, PET/MRI, chemoradiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 12 Dec 2019 (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.
Comparing FDG PET/CT and FDG PET/MRI in the diagnostic accuracy of detecting local recurrence 12 weeks after the end of CRT in head and neck squamous cell carcinoma patients. Forty patients aged more than 18 years who have a histologically confirmed HNSCC and have received chemoradiation therapy will be recruited for the study. The patients will be scanned with both PET/CT and PET/MRI 12 weeks after the end of CRT.
Detailed description
Since recurrence of HNSCC occurs in up to 50 percent of cases in the first two years following treatments and the recurrent diseases are less responsive to new treatments, detecting local/regional recurrence at an earlier time is crucial in order to provide salvage treatments. The primary objective of this prospective study is to compare the diagnostic accuracy of FDG PET/CT to FDG PET/MRI in the detection of local recurrence 12 weeks after the end of chemoradiation treatment in HNSCC patients. The hypothesis is that PET/MRI might be able to diagnose locoregional recurrence earlier and more accurately which would lead to a better outcome for the patient. If it is proven correct, it would be possible to optimize the use of PET/MRI imaging on selected patients who are likely to benefit clearly from the use of that modality.
Forty patients aged more than 18 years who have a histologically confirmed HNSCC and have received chemoradiation therapy will be recruited for the study. The patients will be scanned with both FDG-PET/CT and FDG-PET/MRI 12 weeks after the end of CRT.
All study participants will be consented, and the estimated time for completing the PET scans of 40 patients will take 12 to 15 months. The results will be reported in international peer-reviewed high-impact journals.
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 HNSCC | Experimental | Diagnostic Test: PET/MRI, Diagnostic Test: PET/CTPatients who have histologically confirmed HNSCC and have received CRT for it |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Language spoken: Finnish or Swedish
- Diagnosis: Histologically confirmed HNSCC
- Chemoradiotherapy treatment with curative intent to the primary tumor and/or neck LN metastasis that has ended 12+- 4 weeks before the PET scan.
- Clinical stage: Stage I-II at least 20 patients, Stage III-IV at least 20 patients
Key exclusion criteria (3 listed)
- Uncontrolled serious infection
- Contraindications for MRI (cardiac pacemaker, intracranial clips etc., allergic reaction to contrast agent)
- Severe claustrophobia
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/MRIeach patient will perform PET/CT and PET/MRI scans in two different days within the interval of less than 2 weeks receiving two different FDG injections. Administered FDG activity for each PET scan will be 4 MBq/Kg up to a maximum of 400 MBq. | Diagnostic test | Patients with HNSCC |
| PET/CTeach patient will perform PET/CT and PET/MRI scans in two different days within the interval of less than 2 weeks receiving two different FDG injections. Administered FDG activity for each PET scan will be 4 MBq/Kg up to a maximum of 400 MBq. | Diagnostic test | Patients with HNSCC |
Primary outcome
Local recurrence
Time frame: 12 weeks after chemoradiotherapy
local recurrence detected with PET/TT vs. with PET/MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Simona Malaspina, MD contact
Jukka Kemppainen, MD PhD principal investigator
Turku University Hospital PET Centre
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 and PET/CT in people with Head and Neck Squamous Cell Carcinoma, 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 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: status not confirmed, as of the sponsor's last update on 13 Apr 2021. 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 Sarita Murtojärvi, MD (+358407734813, sarita.murtojarvi@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence (time frame: 12 weeks after chemoradiotherapy). 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 13 Apr 2021.