NCT04196985

18F-FDG PET/CT Versus 18F-FDG PET/MRI in Detecting Locoregional Recurrence 3 Months After CRT in Head and Neck SCC

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Turku University Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PET/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_TEST	PET/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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-10-01
• Completion: 2024-10-01
• First posted: 2019-12-12
• Last updated: 2021-04-13

Locations

1 site across 1 country: Finland