Trial Title:
Smart Optical and Ultrasound Diagnostic of Breast Cancer
NCT ID:
NCT05916703
Condition:
Breast Disease
Conditions: Official terms:
Breast Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
SOLUS examination
Description:
The examination of each subject will include: i) B-mode US, ii), color Doppler US, iii)
shear wave elastography, and iv) SOLUS multimodal imaging.
For each subject various ultrasound images (modalities i-iii) will be taken and these
images will determine the location for the SOLUS measurements (iv).
All measurements (i-iv) will be taken at the lesion location, in the normal breast tissue
around the lesion, and in the mirror location of the contralateral breast.
Optically derived data (blood volume, blood oxygen saturation, water, lipid and collagen
concentrations, tissue scattering parameters) will be obtained. Every subject included in
the study will be evaluated separately by 3 radiologists, with different level of
experience in breast imaging.
Arm group label:
SOLUS examination arm
Summary:
SOLUS is a trans-disciplinary 48-month project bringing together 9 partners: industries
(4), academic and clinical institutions from 5 countries (engineers, physicists and
radiologists) representing cutting-edge expertise in their fields, to develop an
innovative non-invasive, point-of-care, low-cost, easy-to-operate, multi-modal imaging
system (diffuse optics and ultrasounds/shear wave elastography) for high-specificity
diagnosis of breast cancer, the most common female cancer in Europe. Mammographic
screening is effective in reducing mortality, however the 10-year cumulative
false-positive risk is 50-60%, leading to needless additional invasive procedures (e.g.
biopsy). The project addresses the unmet clinical need for higher specificity in breast
cancer imaging following screening by fully combining photonics with non-photonics
techniques, developing and clinically validating innovative and previously unthinkable
photonics concepts and components: time-domain small source-detector distance optical
tomography, miniaturized picosecond pulsed laser sources, high-dynamic-range time-gated
single-photons detectors to achieve unprecedented sensitivity and depth penetration. For
the first time, this allows a comprehensive quantitative characterization of breast
tissue including composition (water, lipids, collagen), functional blood parameters,
morphologic information and mechanical parameters (stiffness). This innovative
multi-parametric characterization will significantly improve the specificity of breast
screening, with great impact on the quality of life of millions of European women every
year, and huge savings for the healthcare systems. The strong involvement of leading
industrial players at all levels in the value chain will push the European innovation
process and make a significant contribution to ensuring Europe's industrial leadership in
the biophotonics healthcare market, while addressing one of the largest societal
challenges in health and well-being.
Detailed description:
The pilot study for validation of the SOLUS system is carried out at the Department of
Breast Imaging of OSR after the ethics and Italian Health Ministry approvals.
Adult women, 20 with malignant and 20 with benign breast lesions visible at US
examination, aged over 18 years, that agree to participate in the study, signing the
informed consent form, will be included. In order to select cases, the investigators will
consider as benign lesions with a clear benign aspect at US, classified as BI-RADS 2
following the ACR classification, unchanged for dimension and morphology from at least 2
years or with a previous CB done at least before 1 year or BI-RADS 2 and 3 lesions
confirmed at histology. The investigators will consider as malignant lesions suspicious
or malignant at US, classified as BI-RADS 4 and 5 following the ACR classification, with
a confirmation of nature at histology done in any modality, with per-cutaneous or
surgical biopsy, after the SOLUS examination. Biopsies will be taken only in case of
individual medical necessity, independent of the result of SOLUS evaluation. The
collection, examination and storage of the bioptic material itself will be done outside
of the SOLUS project, in accordance with clinical procedures. The SOLUS project will only
use the results of these bioptic examinations. In case of biopsy, patients will be asked
to sign also an informed consent to the usage of bioptic results for the research. Biopsy
will be performed after the multi-modal examination, in order to avoid possible artifacts
caused by biopsy-induced swelling, bruising or bleeding. Thus, more than 20 cases in each
group of breast lesions will have to be evaluated and identified at US and selected for
the study to obtain the 20 benign and 20 malignant lesions confirmed at histology or at
long observation in case of well know benign nodules, useful for our study. The
examination of each subject will include: i) Conventional B-mode US, ii), color Doppler
US, iii) shear wave elastography (SWE), and iv) SOLUS multimodal imaging.
Conventional B-mode US (i), color Doppler US (ii) and SWE (iii) will be performed
preliminary to the SOLUS scan.
A detailed evaluation of the lesions by means of the following established US parameters
to evaluate benignity and malignancy suggestive parameters will be carried out:
morphology, margins, echogenicity (hyper-, iso-, or hypoechogenicity with respect to
normal breast parenchyma), in agreement with BI-RADS classification, presence or absence
of the halo sign, presence of spot microcalcifications, and Doppler color flow. The US
elastogram will be displayed over the B-mode image in a color scale that ranges from blue
(low stiffness) to red (high stiffness).
For each subject various ultrasound images (modalities i-iii) will be taken. These images
will determine the location for the SOLUS measurements (iv) and provide information about
the depth and thickness of the breast lesion and distance between the skin surface and
the lesion. SOLUS multimodal imaging (iv) will be performed using a similar procedure as
for US, Doppler and elastography. For each imaging procedure, subjects will be examined
in the supine position, as for a traditional breast US examination.
All measurements (i-iv) will be taken at the lesion location, in the normal breast tissue
around the lesion (ipsi-control measurement), and in the mirror location of the
contralateral breast (contra-control measurement).
Every subject included in the study will be evaluated separately by 3 radiologists, with
different level of experience in breast imaging, in blind. Coordinated by the principal
investigator, they will perform an US examination on each subject, focused on the target
nodule, reporting data results from US examination, color Doppler, elastography and
SOLUS. This will allow us to verify the reproducibility of the data obtained and the
agreement among operators.
Optically derived data (blood volume, blood oxygen saturation, water, lipid and collagen
concentrations, tissue scattering parameters) will be obtained as quantitative variables.
Each variable will be first separately analyzed and data between benign and malignant
breast lesions will be compared. Then, composite variables will be explored, looking for
"synthetic" indexes to maximize the diagnostic effectiveness. A preliminary receiver
operating characteristic curve will be derived using the clinical diagnosis as the
gold-standard for each variable. This will not be a statistically strong data set, but it
will allow the investigators to explore the hypotheses that SOLUS detects a contrast in
the lesions and that contrast reflects the lesion nature. These steps will be made first
considering optically-derived variables and then combining variables obtained with all
SOLUS modalities.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- women over 18 years of age
- subject with a breast lesion visible at US, either:
- benign, classified as benign lesions at previous US and unchanged for at least 2
years or with a previous core biopsy done at least 1 year before or BI-RADS 2 or 3,
confirmed at histology after SOLUS examination
- or malignant, classified as BI-RADS 4 or 5, confirmed at histology after SOLUS
examination
Exclusion Criteria:
- subject is pregnant, breast feeding
- subject is unable or unwilling to give informed consent
- previous core biopsy of the same breast, performed in the last year
- previous breast surgery of the same breast
Gender:
Female
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ospedale San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
PIETRO PANIZZA
Email:
panizza.pietro@hsr.it
Start date:
November 11, 2021
Completion date:
December 2023
Lead sponsor:
Agency:
IRCCS San Raffaele
Agency class:
Other
Collaborator:
Agency:
Politecnico di Milano
Agency class:
Other
Collaborator:
Agency:
Commissariat A L'energie Atomique
Agency class:
Other
Collaborator:
Agency:
SuperSonic Imagine
Agency class:
Industry
Collaborator:
Agency:
VERMON
Agency class:
Other
Collaborator:
Agency:
University College, London
Agency class:
Other
Collaborator:
Agency:
MICRO PHOTON DEVICES (MPD)
Agency class:
Other
Collaborator:
Agency:
EIBIR - European Institute for biomedical imaging research
Agency class:
Other
Collaborator:
Agency:
IC-HAUS
Agency class:
Other
Source:
IRCCS San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05916703
