Clinical trial NCT03160495: Functional ImaGing of Heterogeneity in Head and Neck Tumors - Validation From Surgical Specimens
Official title: Functional ImaGing of Heterogeneity in Head and Neck Tumors - Validation From Surgical Specimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: PET/MR
Squamous cell carcinoma
Heterogeneity
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Please see detailed description

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantified measures from FDG PET and pathology
timeFrame: 3-6 months
measure: Quantified measures from DWI and pathology
timeFrame: 3-6 months
measure: Quantified measures from DCE and pathology
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Otorhinolaryngology, Head & Neck Surgery and Audiology Rigshospitalet, University of Copenhagen
Study officials:
References: