1. To investigate the feasibility of photoacoustic breast cancer imaging as embodied in the first generation photoacoustic mammoscope; 2. To correlate the photoacoustic images to conventional diagnosis of the breast and therefore to find…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Photoacoustic images will be compared with the outcomes of clinical
investigation, conventional imaging, optical properties of healthy and
malignant tissue and pathology. In the first stage of the study (3 months, 10
patients), the photoacoustic images will mainly be used to optimize the
measurement and analysis methods. In the second stage of the study (18 months
50-70 patients), the images of the BIRADS 4 and 5 lesions will qualitatively be
described in order to find photoacoustic markers that are indicative for
malignancy and how they are related tot he optical properties of the patients
breast tissue. In the third stage of the study (3 months, about 20 patients),
which will only be reached if the results of the first two phases are
promising, also non-cancerous breast (normal breast tissue and benign lesions -
BIRADS 1,2)) will be investigated for the presence of the photoacoustic
malignancy markers.
Secondary outcome
not applicable
Background summary
Breast cancer is one of the most common forms of female cancer worldwide. There
are major limitations to the current imaging techniques that are used for
diagnosing breast cancer. There is no single technique that combines an
excellent sensitivity with a good specificity, an appropriate resolution and a
high imaging contrast and that can be used in the whole adult female
population. Furthermore, of the conventional imaging techniques, X-ray
mammography uses potential hazardous ionizing radiation and MRI requires
injection of contrast agents. In the last years, researchers at the University
of Twente have made progress in the development of a new technique for breast
cancer imaging: photoacoustic mammography. This technique combines the high
contrast of optical imaging with the good resolution of ultrasound. Besides,
the contrast is based on functional processes and provides, in theory, a higher
sensitivity and specificity than X-ray mammography and ultrasonography.
Photoacoustic imaging does neither require ionizing radiation nor contrast
agents and does not exclude people with pacemakers. It is expected that the
imaging is not influenced by the density of the breast and, therefore, that it
can also be used in younger high-risk women. The clinical feasibility of
photoacoustic mammography has been tested with realistic breast phantoms and in
a small pilot study. We are now at the stage that a lot of clinical data is
needed in order to guide the developments of this technique and to find
photoacoustic parameters that are indicative for malignancy.
Study objective
1. To investigate the feasibility of photoacoustic breast cancer imaging as
embodied in the first generation photoacoustic mammoscope;
2. To correlate the photoacoustic images to conventional diagnosis of the
breast and therefore to find photoacoustic markers that are indicative for
malignancy (phase 1 and 2);
3. To determine the optical characterization of and differentiation between
benign and malignant breast tissue (phase II: DPS)
4. To effect technological changes based on clinical and patient*s experiences,
and to use the results in the development of the second generation
photoacoustic mammoscope (phase 1-3);
5. To find the appropriate image analysis methods in order to get the best
contrast between cancerous and non-cancerous breast tissue within the patient
(phase 1-3).
Study design
This study will be an observational and diagnostic study. The study will be
divided into three stages. The total study will last for 2 years and a maximum
number of 100 women will be included.
Study burden and risks
Because we want to investigate the clinical feasibility of photoacoustic
imaging in symptomatic women, patients from the outpatient*s breast clinic are
needed. No risks are expected for the patients participating in the study and
the burden is only minimal. There is no individual benefit for the patients
participating in this study. The benefit of this study is concerning a large
amount of the future breast cancer population.
Dienstweg 1
Enschede 7522 NB
NL
Dienstweg 1
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
Photoacoustic part:
1)Adult women, who come to the Centre for Mammacare with a lesion suspicious for malignancy that, after clinical investigation and anamnesis is classified as a BIRADS 3-5 (phase 1 and 2) or a BIRADS 1 or 2 (phase 3) lesion. In addition the lesion or suspect must have been deemed as being manifestable in a photoacoustic examination;
2) Patients in good general health that allows them to undergo the examination in a prone position for a period of 45 minutes;
3) Patients who are fully competent to give informed consent.;DPS part:
1) all inclusion criteria for photoacoustic imaging;
2) patient who gave informed consent for the photoacoustic imaging study;
3) patient who will have a ultrasound-guided breast biopsy to investigate the lesion, which should be accessible with the VACORA biopsy system.
Exclusion criteria
Photoacoustic part:
1) Patients whose physical condition is expected to be insufficient for mounting the examination bed and staying on this bed for 45 minutes without too much discomfort;
2) Patients who had a breast biopsy in 3 months prior to this study;
3) Patients with bloody discharge, ulcers or wounds on the breast;
4) Patients with a history of surgery or radiation therapy on the breast;
5) Patients who are currently undergoing chemotherapy.;DPS part
1) all under 'photoacoustic part'
2) patient who don't gave informed consent for the photoacoustic part
3) patient who use anticoagulantia;
4) patients from which the lesion is inaccessible with the VACORA biopsy needle.
Design
Recruitment
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 | NL30718.044.09 |
| Other | TC=2945 (Nederlands Trial Register) |