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

April 8, 2021 updated by: Turku University Hospital

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.

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Patients with HNSCC
Patients who have histologically confirmed HNSCC and have received CRT for it
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local recurrence
Time Frame: 12 weeks after chemoradiotherapy
local recurrence detected with PET/TT vs. with PET/MRI
12 weeks after chemoradiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Jukka Kemppainen, MD PhD, Turku University Hospital PET Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HENEPET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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