Functional ImaGing of Heterogeneity in Head and Neck Tumors - Validation From Surgical Specimens

Completed

• Conditions: Squamous Cell Carcinoma of the Head and Neck

• Registration Number: NCT03160495
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

The purpose of this study is to investigate if heterogeneity in head and neck squamous cell carcinoma as seen in functional imaging with PET/MR can be correlated to biologic heterogeneity in surgical specimens.

Detailed Description

The following is a presentation of a prospective protocol, named FIGHHT, including patients with squamous cell carcinoma of the head and neck (HNSCC) who are referred for surgery.

This is a prospective imaging/biomarker expression study where patients referred for surgery for HNSCC will be included. The purpose of the study is to investigate if heterogeneity in HNSCC as seen in functional imaging with PET/MR can be correlated to biologic heterogeneity in surgical specimens.

Multiparametric imaging(MPI) is performed before surgery using a PET/MR system (Siemens Biograph mMR) with a 3 T magnet using a head and neck coil. The scan protocol includes diffusion weighted MRI, dynamic contrast enhanced perfusion MRI and FDG-PET (4 MBq/kg). Morphometric imaging is performed with a 3D T2 weighted sequence (SPACE, voxel size 1.0 mm isotropic in vivo and 0.5 mm isotropic for specimens).

The scans are evaluated by a radiologist and a specialist in nuclear medicine and regions of interest and reference areas (anatomical landmarks) are marked. The tumor and if indicated lymp nodes are removed en bloc and per-operatively the reference areas and other anatomical landmarks are marked in the specimen with intravenous tubes. The specimen is fixed to a corkboard and scanned morphometric (as described) using a knee coil before and after formalin fixation within 1 hour after surgery. The whole surgical specimen is sectioned for histological processing.

Tissue blocks will undergo microscopic pathological evaluation and IHC staining. The specific selection of cancer related IHC biomarkers is based on their relationship with tumor cell metabolism, radiotherapy resistance (proliferation and hypoxia), association with FDG accumulation and institutional experience from a previous study.

The quantified measurements from the FDG PET, DWI and DCE scan will be correlated to the expression of IHC biomarkers.

Study Timeline

• Study Start: 2017-03-29
• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-19
• Primary Completion: 2018-09-30
• Study Completion: 2018-12-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Informed consent
• Age above 18
• Primary or recurrent squamous cell carcinoma in the head and neck area
• Referred to surgery
• Primary tumor > 1.5 cm and or neck metastasis of more than 1 cm.

Exclusion Criteria

• Patient refusal

• Contraindications for FDG-PET/MR scan

  • Pacemaker
  • Severe claustrophobia
  • Magnetic metal in the body that is not MR compatible

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantified measures from FDG PET and pathology	3-6 months	Correlation between FDG uptake (measured as SUV) and expression of IHC biomarkers
Quantified measures from DWI and pathology	3-6 months	Correlation between diffusion weighted imaging and expression of IHC biomarkers
Quantified measures from DCE and pathology	3-6 months	Correlation between dynamic contrast enhancement and expression of IHC biomarkers

Trial Locations

Locations (1)

Department of Otorhinolaryngology, Head & Neck Surgery and Audiology Rigshospitalet, University of Copenhagen; 🇩🇰 Copenhagen, Denmark