Primary: To investigate the performance of the PAM3(+) device in breast cancer imaging. With the performance we mean:1. The ability to visualize blood vessels and tumors in the mammary gland (PA)2. To extract oxygenation saturation estimations (QPAT…
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 deliverable is a set of PA/USCT breast images from healthy breasts,
breasts containing malignant lesions, breasts containing benign lesions and all
contralateral breasts. Furthermore, images acquired using conventional imaging
modalities: x-ray and/or US and MRI will be collected in stage 2. For the
patients who had to undergo a biopsy, we will also perform extensive pathology
investigations as described in the study design.
Secondary outcome
We ask the radiologists to evaluate the breast density based on the MMG
investigation. With this knowledge we can investigate the imaging performance
and sensitivity of the PAM3(+) device in breasts with different densities.
All subjects will be asked to fill out a questionnaire. The questionnaire (F1)
can be 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).
This questionnaire gives us the opportunity to answer the following set of
questions:
• Does the breast size influence the imaging performance and sensitivity of the
PAM3(+) device?
• Does the menstrual cycle influence the imaging performance and sensitivity of
the PAM3(+) device?
Other interesting questions may be defined during the study
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 two
generations Twente photoacoustic mammoscopes (PAM 1 & PAM 2) were tested in the
clinic. PAM 1 was able to visualize known breast malignancies, and in PAM 2 the
imaging quality was improved. We are now working with our (technically
improved) third generation system (the PAM3(+) device), which is a hybrid
system by combining PA with ultrasound computed tomography (USCT). We hope to
visualize more anatomical information about the tumor by the combination of
these modalities. The PAM3(+) device has so far not been tested in a clinical
setting. In this study, we want to investigate the feasibility of the PAM3(+)
device in breast cancer imaging. The PAM3(+) system performance will be
measured by comparing the obtained images of benign and malignant lesions to
those of conventional imaging techniques (x-ray mammography, ultrasonography,
MRI) and pathology results. Next to that, feasibility measurements will be
performed with healthy volunteers.
Study objective
Primary: To investigate the performance of the PAM3(+) device in breast cancer
imaging. With the performance we mean:
1. The ability to visualize blood vessels and tumors in the mammary gland (PA)
2. To extract oxygenation saturation estimations (QPAT)
3. To visualize the breast morphology (USCT)
Secondary:
• To optimize the measurement protocol and general system performance;
Optimize patient positioning and breast stabilization
To develop an appropriate image reconstruction algorithm in
order to obtain an optimal contrast and resolution;
• To investigate the ability of the PAM3(+) device to assess lesion location
and size;
• To find out whether the PAM3(+) device is able to visualize the entire
mammary gland;
Investigating whether the blood present in the pectoralis
major muscle, positioned underneath the mammary gland can be visualized.
• To correlate PA/USCT breast images to clinical, pathological and conventional
imaging, in order to find PA image descriptors;
• To start with the development of a PA/USCT lexicon, as a lead for
radiologists to come to a diagnosis.
• To deduce additional criteria to be implemented in future clinical trials
with the PAM3(+) device;
Study design
This study is an observational feasibility study consisting of 2 stages. In the
first stage the measurement procedure will be optimized using healthy subjects
(maximum of 30 (2x15)). The second stage consists of a clinical feasibility
study, performing the PAMMOTH measurements and in some cases MRI next to the
normal workup in a maximum of 130 patients who present at the Centres for
Mammacare with an anomaly in the breast.
Study burden and risks
Subjects in stage 2 will already be visiting this outpatient breast clinic. The
PA and USCT investigations will be performed after the MMG and/or US
investigations, but before the MRI and/or biopsy investigations. The patient
will join the PAM3(+) study in the time the radiologists have to evaluate the
acquired MMG and/or US images to decide upon the next steps. Patients who have
to undergo a MRI investigation according to the normal work-up, which generally
consists of BIRADS 3, 4 or 5 patients, will not experience any extra burden by
participating in our study. However, patients from the MST who don*t have to
undergo a MRI for their own standard diagnostic work-up (generally BIRADS 2),
but do want to participate in our study will experience a slightly increased
burden since they have to undergo an additional MRI investigation. This implies
that we need an hour more of these patient*s time and that the patient has to
travel to the MST in Enschede to undergo this extra MRI. Additional findings
rising from the MRI will, in case of BIRADS-3 or higher, bring additional
diagnostics. This will only be applicable to a few patients. The patients will
be informed about this.
Drienerlolaan 5
Enschede 7522 NB
NL
Drienerlolaan 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers:
- Adult women;
- Subjects who are fully competent to give informed consent.
Extra criteria for patients:
- Adult women who present at the Centre for Mammacare with an anomaly in the
breast, which, after clinical investigation and diagnostic imaging is suspect
to be of an ICNST, ILC, DCIS, FA or cyst;
- Subjects who are fully competent to give informed consent.
Exclusion criteria
Healthy volunteers:
- Subjects with a (history of) breast disease;
- Subjects with a tattoo or irremovable piercings on/in the breast;
- Subjects who are pregnant or who are breastfeeding.
- Subjects with a known allergy for PVC
- Subjects who are not physically capable of climbing on the examination bed,
who*s breast are too big to fit in the cup sizes or are not capable to lay
still in prone position for the requested examination time.
Criteria for patients:
- Subjects who had a breast biopsy in the 6 months prior to this study;
- Subjects with bloody discharge, breast ulcers or -wounds;
- Subjects with a history of surgery (including cosmetic surgery) or radiation
therapy on the breast;
- Subjects who are currently undergoing chemotherapy;
- Subjects with a tattoo or irremovable piercings on/in the breast;
- Subjects who are pregnant or who are breastfeeding;
- Subjects with contra-indication for breast MRI. (only in Medisch Spectrum
Twente)
- Subjects with a known allergy for PVC
- Subjects who are not physically capable of climbing on the examination bed,
who*s breast are too big to fit in the cup sizes or are not capable to lay
still in prone position for the requested examination time.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL71091.100.19 |
| Other | NL7992 |