18F-FDG PET/CT Versus 18F-FDG PET/MRI in Detecting Locoregional Recurrence 3 Months After CRT in Head and Neck SCC (HENEPET)
Primary Purpose
Head and Neck Squamous Cell Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
PET/MRI
PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Squamous Cell Carcinoma focused on measuring PET-imaging, local recurrence, PET/MRI, chemoradiotherapy
Eligibility Criteria
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
Sites / Locations
- Turku PET CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with HNSCC
Arm Description
Patients who have histologically confirmed HNSCC and have received CRT for it
Outcomes
Primary Outcome Measures
Local recurrence
local recurrence detected with PET/TT vs. with PET/MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT04196985
First Posted
November 20, 2019
Last Updated
April 8, 2021
Sponsor
Turku University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04196985
Brief Title
18F-FDG PET/CT Versus 18F-FDG PET/MRI in Detecting Locoregional Recurrence 3 Months After CRT in Head and Neck SCC
Acronym
HENEPET
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
Keywords
PET-imaging, local recurrence, PET/MRI, chemoradiotherapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with HNSCC
Arm Type
Experimental
Arm Description
Patients who have histologically confirmed HNSCC and have received CRT for it
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/MRI
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Local recurrence
Description
local recurrence detected with PET/TT vs. with PET/MRI
Time Frame
12 weeks after chemoradiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarita Murtojärvi, MD
Phone
+358407734813
Email
sarita.murtojarvi@tyks.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Simona Malaspina, MD
Email
simona.malaspina@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jukka Kemppainen, MD PhD
Organizational Affiliation
Turku University Hospital PET Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku PET Centre
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simona Malaspina, MD
Email
simona.malaspina@tyks.fi
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
18F-FDG PET/CT Versus 18F-FDG PET/MRI in Detecting Locoregional Recurrence 3 Months After CRT in Head and Neck SCC
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