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

March 25, 2019 updated by: Jacob Rasmussen, Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Otorhinolaryngology, Head & Neck Surgery and Audiology Rigshospitalet, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Please see detailed description

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 29, 2017

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

December 30, 2018

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (ACTUAL)

May 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-16049387

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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