Diffuse Optical Tomography (DOT) and Magnetic Resonance Imaging (MRI) image fusion, development of methods in volunteers and validation in patients with benign cysts of the breast

Imaging techniques play an important role in breast cancer management. The
currently used modalities like X-ray mammography, Ultrasound and Magnetic
Resonance Imaging have important limitations like low sensitivity, high costs,
the use of ionizing radiation or compression of the breast.
Diffuse Optical Tomography (DOT) imaging provides three dimensional images of
optical characteristics of the breast using near infrared light only and
without breast compression. At the University Medical Center Utrecht, studies
using the Philips Medical Systems - Diffuse Optical Tomography (PMS-DOT)
Prototype have been carried out in 2006-2007 with promising results. However,
the prototype was not yet competing with standard diagnostic modalities.
Within the Centre for Translational Molecular Medicine (CTMM) - Mammary
Carcinoma Molecular Imaging for Diagnosis and Therapeutics (MAMMOTH) project,
breast cancer targeting probes are being developed, conjugated to fluorescent
dye and made suitable for human optical imaging. This Fluorescence Molecular
Imaging should greatly improve diagnostic performance and even holds the
promise to outperform anatomical imaging modalities in the future. As
fluorescence molecular imaging of the human breast is an uncharted area and
previous clinical trials have indicated the anatomical information obtained
from optical imaging is minimal, co-registration with an anatomical imaging
modality such as Magnetic Resonance Imaging (MRI) will be necessary for further
development. In this way, the interpretation of DOT-images will be ameliorated
in upcoming fluorescence molecular imaging trials.

The purpose of this study is to develop and validate methods to fuse the
molecular information of DOT-images with anatomical information of MRI-images
of the human breast.

This single center observational clinical study consists of a
methods-development part (A) and a validation part (B).
In part A, healthy female volunteers will be imaged on the PMS-DOT system and
MRI. Fusion methods will be adapted making use of the the collected data. In
part B, patients diagnosed with ultrasound proven benign cysts will be imaged
on both modalities to validate the methods developed in part A.

Optical imaging is a safe investigational procedure, the PMS-DOT system meets
the Medical Device Directive requirements. The lasers are not harmfull, the
optical matching fluid is biocompatible. No ionizing radiation is used and the
breast is not compressed. Magnetic Resonance Imaging is a safe technique and
commonly used in daily medical practice. No contrast agent is used.
The estimated risk classification for this study: minimal exceeding of
negligible risk.