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

NCT04196985 | Unknown

• 1 other identifier: HENEPET
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

PET-imaging; local recurrence; PET/MRI; chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Local recurrence

  local recurrence detected with PET/TT vs. with PET/MRI

  12 weeks after chemoradiotherapy

Study Arms (1)

Patients with HNSCC

EXPERIMENTAL

Patients who have histologically confirmed HNSCC and have received CRT for it

Diagnostic Test: PET/MRI; Diagnostic Test: PET/CT

Interventions

PET/MRI DIAGNOSTIC_TEST

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.

Patients with HNSCC

PET/CT DIAGNOSTIC_TEST

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.

Patients with HNSCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled serious infection
• Contraindications for MRI (cardiac pacemaker, intracranial clips etc., allergic reaction to contrast agent)
• Severe claustrophobia

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku PET Centre

Turku, Finland

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Jukka Kemppainen, MD PhD

  Turku University Hospital PET Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarita Murtojärvi, MD

CONTACT

+358407734813; sarita.murtojarvi@tyks.fi

Simona Malaspina, MD

CONTACT

simona.malaspina@tyks.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: December 12, 2019
• Study Start: October 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2024
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

FI (1)