Primary objective: To investigate the feasibility of PAM 2 in breast cancer imaging, characterizing the photoacoustic appearances of different types of malignant (stage 1A) and benign (stage 1B) lesions.Secondary objectives:- To test the measurement…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is a set of photoacoustic breast images from healthy
breasts, breasts containing malignant lesions and breasts containing benign
lesions. Photoacoustic images will be qualitatively described and compared to
the outcomes of clinical investigation, conventional imaging and pathology. In
stage 1A and 1B, we want to find photoacoustic markers indicative for malignant
respectively benign lesions. The presence or absence of markers of malignancy
will be evaluated in stage 1B. In both stages, photoacoustic appearance of
healthy (contralateral) breasts will be investigated.
Secondary outcome
All subjects will be asked to fill out a questionnaire. The questionnaire will
contain questions on:
- Comfort / burden of the measurement;
- Personal information such as age, height, weight, breast size and moment in
menstrual cycle at the time of measurement (if applicable).
Background summary
Breast cancer is the most common type of female cancer worldwide. Early
detection has proven to have a positive influence on the prognosis and survival
rate. An important aid in the detection and diagnosis of breast cancer is the
use of medical imaging techniques. Conventionally used imaging techniques
(x-ray mammography, ultrasonography, MRI) have their limitations and drawbacks.
In the past years, a new method of imaging called photoacoustics (PA) has been
developed and applied for breast cancer imaging at the University of Twente. PA
combines high optical contrast with high ultrasound resolution. The contrast in
PA is based on light absorption by an increased amount of hemoglobin in and
around malignancies. The method is non-invasive and is harmless. The first
generation Twente photoacoustic mammoscope (PAM 1) was tested in the clinic and
was able to visualize known breast malignancies. We are now working with our
(technically improved) second generation photoacoustic mammoscope (PAM 2),
which has so far not been tested in a clinical setting. We want to investigate
the feasibility of PAM 2 in breast cancer imaging. The PAM 2 system performance
will be measured by comparing the obtained images of benign and malignant
lesions to those of conventional imaging techniques and pathology results. Next
to that, feasibility measurements will be performed with healthy volunteers.
Study objective
Primary objective:
To investigate the feasibility of PAM 2 in breast cancer imaging,
characterizing the photoacoustic appearances of different types of malignant
(stage 1A) and benign (stage 1B) lesions.
Secondary objectives:
- To test the measurement protocol and general system performance;
- To correlate photoacoustic breast images to clinical, pathological and
conventional imaging in order to find photoacoustic image descriptors and
investigate the ability of PAM 2 to assess lesion location and size;
- To find out whether PAM 2 is able to visualize the entire mammary gland;
- To develop an appropriate image reconstruction algorithm in order to obtain
an optimal contrast and resolution;
- To deduce potential exclusion criteria to be implemented in future clinical
studies with the PAM 2 (stage 2, will be submitted separately to the METC in
future).
Study design
This study will be an observational, diagnostic study. The study will be
divided into stage 0, stage 1A and stage 1B. The study will last one year and a
maximum number of 130 subjects will be included, divided over stage 0, 1A and
1B.
Study burden and risks
In order to get a first indication of the performance of the system, we need to
image healthy subjects, subjects with malignant lesions as well as subjects
with benign lesions and contralateral healthy breasts. This makes the study
group-related to healthy volunteers and to patients who come to the mammapoli
MST with either a BI-RADS 2 or 3 or a BI-RADS 4 or 5 lesion. The expected risk
is negligible and the burden is minimal. There is no individual benefit for
subjects participating in the study. The benefit is aimed at the future breast
cancer population.
Drienerlolaan 5
Enschede 7522 NB
NL
Drienerlolaan 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
Stage 0:
- Adult women;
- Subjects who are fully competent to give informed consent.;Stage 1:
- Adult women who come to the mammapoli with a lesion suspicious for malignancy, which, after clinical investigation and diagnostic imaging is classified as BI-RADS 4 or 5 (stage 1A), or BI-RADS 2 or 3 (stage 1B);
- Subjects who are fully competent to give informed consent.
Exclusion criteria
Stage 0:
- Subjects who have a cup size of D or larger;
- Subjects who have symptoms of breast cancer such as a palpable mass which might be attributed to breast cancer;
- Subjects who have had (a) benign breast lesion(s) in the past;
- Subjects who have had breast cancer in the past;
- Subjects who had a breast biopsy in the 6 months prior to this study;
- Subjects with bloody discharge, ulcers or wounds on the breast;
- Subjects with a history of surgery (including cosmetic surgery) or radiation therapy on the breast;
- Subjects who are currently undergoing chemotherapy.;Deel 1:
- Subjects who have a cup size of D or larger;
- Subjects who had a breast biopsy in the 6 months prior to this study;
- Subjects with bloody discharge, ulcers or wounds on the breast;
- Subjects with a history of surgery (including cosmetic surgery) or radiation therapy on the breast;
- Subjects who are currently undergoing chemotherapy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL55871.044.15 |
| OMON | NL-OMON20184 |