Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
PET-imaging, local recurrence, PET/MRI, chemoradiotherapy
Brief 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 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.
Interventions
DIAGNOSTIC_TESTPET/MRI
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.
DIAGNOSTIC_TESTPET/CT
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.
Sponsors
Turku University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence | 12 weeks after chemoradiotherapy | local recurrence detected with PET/TT vs. with PET/MRI |
Countries
Finland
Contacts
Primary ContactSarita Murtojärvi, MD
Backup ContactSimona Malaspina, MD
Outcome results
None listed