The purpose of this study is to determine whether optical mammography performed on the PMS DOT has a potential in breast cancer diagnosis in patients with suspicious breast lesions.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number and size of lesions and location within the breast will be recorded. The
characteristics concerning contrast intensity and direction (i.e. higher or
lower signal compared to background), and homogeneity will be scored for each
lesion. The nature of the lesions (malignant/benign) will be determined by
MR-mammography, and, if necessary, pathology report (reference standard).
The safety of the PMS DOT system will also be assessed.
Secondary outcome
not applicable
Background summary
Imaging techniques play an important role in breast cancer management. The
currently used X-ray mammography has important limitations, such as its limited
use in dense breast tissue and low sensitivity. Magnetic Resonance (MR)
mammography is able to improve these issues only to some extent and is costly
and time-consuming. Consequently, there is an urgent need for a low-cost,
high-speed, accurate imaging tool of the breast. Optical mammography has great
potential. A technologically advanced optical mammography system has recently
been developed: the Philips Medical Systems Diffuse Optical Tomography system
(from here onwards referred to as PMS DOT). It uses near infrared light at 4
different wavelengths to compose images of the optical properties of breast
tissue. The relative concentrations of haemoglobin, lipid, and water can then
be calculated. This could make discrimination between benign and malignant
lesions possible, as has already been described in several clinical studies.
Study objective
The purpose of this study is to determine whether optical mammography performed
on the PMS DOT has a potential in breast cancer diagnosis in patients with
suspicious breast lesions.
Study design
This study consists of two parts. In Part A, 5 patients will be examined on PMS
DOT to optimize the usage of the optical imager in order to streamline the
study; In Part B, 25 patients will be asked to enter this study. The PMS DOT
will be validated as part of the CE certification. This study is a first step
towards using the PMS DOT in combination with a fluorescent contrast agent for
the assessment of breast lesions.
The patients will be imaged on the PMS DOT system and they will undergo
MR-mammography. Optical images will be obtained of both breasts. Evaluation
contains the detection of lesions compared to MR-mammography.
Study burden and risks
The burden for participants is minimal: the optical investigations are
non-invasive, not painful and not time-consuming (2 x 9 minutes). The safety
risk related to the system expected is considered minimal, when entering this
study. The system safety is not hampered, because: 1) Fluids, which come into
contact with the skin, are biocompatible; 2) Lasers will satisfy the European
Standard EN 60825-1 Safety of laser products Part 1; 3) A Hazard Analysis is
held and follow up actions are executed. MRI is not harmful either, no ionizing
radiation is used. The duration of MRI is 30 minutes at maximum.
postbus 10.000
5680 DA Best
Nederland
postbus 10.000
5680 DA Best
Nederland
Listed location countries
Age
Inclusion criteria
BIRADS 2-5 on X-ray mammography
Patients should have both breasts
Age > 18 years
Exclusion criteria
recent breast biopsy/fine needle aspiration
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL11286.041.06 |