An observational study in Squamous Cell Carcinoma of the Head and Neck, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-26.
Sponsored by Rigshospitalet, Denmark · Observational
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.
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.
1,772 studies on the registry are indexed under Carcinoma, Squamous Cell; 412 are open to participants now.
This study's enrollment of 33 is below the median of 100 across 268 observational studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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Please see detailed description
Exclusion Criteria:
Contraindications for FDG-PET/MR scan
All patients are scanned with PET/MR prior to surgery.
Quantified measures from FDG PET and pathology
Correlation between FDG uptake (measured as SUV) and expression of IHC biomarkers
Time frame: 3-6 months
Quantified measures from DWI and pathology
Correlation between diffusion weighted imaging and expression of IHC biomarkers
Time frame: 3-6 months
Quantified measures from DCE and pathology
Correlation between dynamic contrast enhancement and expression of IHC biomarkers
Time frame: 3-6 months
Plan to share: No
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark