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

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

— FIGHHT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160495
• Other study ID #: H-16049387
• Status: Completed
• Start date: March 29, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: March 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 30, 2018
• Est. primary completion date: September 30, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Otorhinolaryngology, Head & Neck Surgery and Audiology Rigshospitalet, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantified measures from FDG PET and pathology	Correlation between FDG uptake (measured as SUV) and expression of IHC biomarkers	3-6 months
Primary	Quantified measures from DWI and pathology	Correlation between diffusion weighted imaging and expression of IHC biomarkers	3-6 months
Primary	Quantified measures from DCE and pathology	Correlation between dynamic contrast enhancement and expression of IHC biomarkers	3-6 months