|- candidate number||27363|
|- NTR Number||NTR6508|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jun-2017|
|- Secondary IDs||NL55871.044.15 / P16-01 ToetsingOnline CCMO / METC Twente|
|- Public Title||Imaging of the breast using light and sound|
|- Scientific Title||Visualizing breast lesions with the second generation Twente photoacoustic mammoscope (PAM 2)|
|- hypothesis||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 is based on light absorption by an increased amount of hemoglobin in and around malignancies. The method is non-invasive and 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.|
|- Healt Condition(s) or Problem(s) studied||Breast cancer|
|- Inclusion criteria||- Adult women who come to the mammapoli with a lesion suspicious for malignancy, which, after clinical investigation and diagnostic imaging is classified as BIRADS 4 or 5, or BIRADS
- Subjects who are fully competent to give informed consent.
|- Exclusion criteria||- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||5-dec-2016|
|- planned closingdate||1-mrt-2018|
|- Target number of participants||120|
|- Interventions||Measurement protocol:|
When a patient comes to the centre for mammacare and meets the inclusion criteria, she is informed about and asked to participate in the study. When she decides to participate, both of her breasts are measured with the PAM 2 system after signing an informed consent form. The subject lies prone on a bed with one of her breasts through a round aperture. Under the bed, the imaging tank filled with warm water was installed, in which the breast hangs freely. The breast is illuminated by a laser and the hereby generated photoacoustic signals are detected by detectors also installed in the imaging tank. The tank rotates around the breast in order to obtain multiple projections. It takes approximately four minutes to image one breast with one excitation wavelength. The contralateral (non-suspect) is also always imaged. Given the two excitation wavelengths the system possesses, the total measurements time will be equal to 16 minutes. However, the subject does not have to lie still for more than four minutes on end. After the measurement, the subject is asked to fill out a questionnaire on her experiences with the measurement and her medical situation. No invasive procedures are performed during the photoacoustic measurement. Laser safety goggles are, under all circumstances, worn by all people present in the measurement room when the laser is operative. The laser fluence on the skin is kept below the maximum permissible exposure (MPE) for skin.
|- 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. Images from the subjects’ breasts taken with conventional imaging modalities are collected (x-ray, ultrasound, MRI, pathology). The main objective is to investigate the feasibility of PAM 2 in breast cancer imaging, characterizing the photoacoustic appearances of different types of malignant and benign lesions. The photoacoustic images are described qualitatively.|
|- Secondary outcome||All subjects are asked to fill out a questionnaire. The questionnaire contains questions on experience with measurement (comfort, burden) and personal questions about for example age, height and medical history.|
|- Timepoints||The photoacoustic measurements are performed when a subject is already at the centre for mammacare (Medisch Spectrum Twente hospital in Oldenzaal, Netherlands) for conventional imaging / diagnosis. After informing her about the study and obtaining informed consent, the photoacoustic measurements are performed. When the measurements are completed, the subject is asked to fill out a questionnaire. Photoacoustic image reconstruction and analysis are conducted afterwards.|
|- Trial web site||n/a|
|- status||recruitement status not public|
|- CONTACT FOR PUBLIC QUERIES||M. Sc. Sjoukje Schoustra|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. ir. Wiendelt Steenbergen|
|- Sponsor/Initiator ||Prof. dr. ir. Wiendelt Steenbergen|
(Source(s) of Monetary or Material Support)
|Stichting Achmea Gezondheidszorg (SAG), Crowdfunding 'Pammografie', Twente Graduate School|
|- Brief summary||Breast cancer is the most common type of female cancer worldwide. Conventionally used imaging techniques (x-ray mammography, ultrasonography, MRI) have their limitations and drawbacks. |
In this observational diagnostic clinical study with our second generation photoacoustic mammoscope (PAM 2), we want to investigate the feasibility of a new method, namely photoacoustics, in breast cancer imaging. The PAM 2 system performance is measured by comparing obtained photoacoustic images to conventional images and pathology results. The aim is to find photoacoustic image descriptors characteristic of malignant and benign breast lesions as well as of the healthy breast.
A maximum of 120 subjects are measured at the Medisch Spectrum Twente hospital in Oldenzaal (Netherlands) after being informed about the study and signing an informed consent form. The study population consists of adult women who come to the hospital with a lesion suspect for malignancy, which, after clinical investigation and diagnostic imaging is classified as BI-RADS 2, 4 or 5. For each subject, the total measurement time is 16 minutes (four times four minutes), during which the subject lies prone on a bed with one of her breasts freely hanging in an imaging tank filled with warm water.
|- Main changes (audit trail)|
|- RECORD||8-jun-2017 - 11-jul-2017|