18F-FDG PET/CT Versus 18F-FDG PET/MRI in Detecting Locoregional Recurrence 3 Months After CRT in Head and Neck SCC (HENEPET)
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)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarita Murtojärvi, MD
- Phone Number: +358407734813
- Email: sarita.murtojarvi@tyks.fi
Study Contact Backup
- Name: Simona Malaspina, MD
- Email: simona.malaspina@tyks.fi
Study Locations
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Turku, Finland
- Recruiting
- Turku PET Centre
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Contact:
- Simona Malaspina, MD
- Email: simona.malaspina@tyks.fi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Uncontrolled serious infection
- Contraindications for MRI (cardiac pacemaker, intracranial clips etc., allergic reaction to contrast agent)
- Severe claustrophobia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Patients with HNSCC
Patients who have histologically confirmed HNSCC and have received CRT for it
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Local recurrence
Time Frame: 12 weeks after chemoradiotherapy
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local recurrence detected with PET/TT vs. with PET/MRI
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12 weeks after chemoradiotherapy
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jukka Kemppainen, MD PhD, Turku University Hospital PET Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HENEPET
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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