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

NCT ID: NCT03160495

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-29
• Study Completion Date: 2018-12-30

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

All patients

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Jacob Rasmussen

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-16049387

Identifier Type: -

Identifier Source: org_study_id