Smart Optical and Ultrasound Diagnostic of Breast Cancer

NCT05916703 | Unknown DMC

• 3 other identifiers: SOLUS46/INT/2021731877
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Disease

Outcome Measures

Primary Outcomes (2)

• Usability

  To test the usability of the novel diagnostic device in the clinical setting through a questionnaire. Three radiologists with different level of experience will apply the protocol on each subject. They will be asked (written questionnaire) to rate (scale 1-5) the probe ergonomics and the overall measurement session duration.

  1 hour

• Clinical validation

  To validate the combined use of clinical US/SWE and optical information for an extensive characterization of breast lesions, collecting morphologic information, stiffness, blood parameters, and tissue composition. A data set including morphologic features, stiffness, blood volume and oxygen saturation, lipids water and collagen content will be collected. Sensitivity, specificity, PPV (positive predictive value) and PNV (positive negative value) of SOLUS will be evaluated using histology or follow up as reference standards.

  1 hour

Study Arms (1)

SOLUS examination arm

EXPERIMENTAL

At least 40 adult women, 20 with malignant and 20 with benign breast lesions visible at US examination, aged over 18 years, will be included.

Diagnostic Test: SOLUS examination

Interventions

SOLUS examination DIAGNOSTIC_TEST

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.

SOLUS examination arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Politecnico di Milano: collaborator
• Commissariat A L'energie Atomique: collaborator
• SuperSonic Imagine: collaborator
• VERMON: collaborator
• University College, London: collaborator
• MICRO PHOTON DEVICES (MPD): collaborator
• EIBIR - European Institute for biomedical imaging research: collaborator
• IC-HAUS: collaborator

Study Sites (1)

Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pietro Panizza, MD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro Panizza, MD

CONTACT

00390226436310; panizza.pietro@hsr.it

Elena Venturini, MD

CONTACT

venturini.elena@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: June 23, 2023
• Study Start: November 11, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)