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Completed

NCT Number: NCT03160495

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Otorhinolaryngology, Head & Neck Surgery and Audiology Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

All patients

Other

All patients are scanned with PET/MR prior to surgery.

Primary outcomes

  1. Quantified measures from FDG PET and pathology

    Time frame: 3-6 months

    Correlation between FDG uptake (measured as SUV) and expression of IHC biomarkers

  2. Quantified measures from DWI and pathology

    Time frame: 3-6 months

    Correlation between diffusion weighted imaging and expression of IHC biomarkers

  3. Quantified measures from DCE and pathology

    Time frame: 3-6 months

    Correlation between dynamic contrast enhancement and expression of IHC biomarkers

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Acronym: FIGHHT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 19, 2017
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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