Innovative imaging system for breast cancer diagnosis
SOLUS Smart Optical and Ultrasound Diagnostic of Breast Cancer
NA · IRCCS San Raffaele · NCT05916703
This study is testing a new imaging system to see if it can help doctors accurately diagnose breast cancer in women with breast lumps without needing to do a biopsy unless it's really necessary.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | IRCCS San Raffaele (other) |
| Locations | 1 site (Milano) |
| Trial ID | NCT05916703 on ClinicalTrials.gov |
What this trial studies
The SOLUS project aims to develop a non-invasive, point-of-care imaging system that combines diffuse optics and ultrasound techniques for the high-specificity diagnosis of breast cancer. This 48-month pilot study will involve adult women with either benign or malignant breast lesions, utilizing a multi-modal approach to improve diagnostic accuracy. Participants will undergo the SOLUS examination, and biopsies will be performed only if medically necessary, ensuring ethical compliance and informed consent. The study is conducted at the Department of Breast Imaging of Ospedale San Raffaele in Milan, Italy.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old with visible breast lesions classified as benign or malignant according to established guidelines.
Not a fit: Patients who are pregnant, breastfeeding, or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this innovative imaging system could significantly reduce false-positive rates in breast cancer screening, leading to fewer unnecessary invasive procedures.
How similar studies have performed: While there have been advancements in breast imaging technologies, the specific combination of techniques in this study represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milano
- Ospedale San Raffaele — Milano, Italy (RECRUITING)
Study contacts
- Principal investigator: Pietro Panizza, MD — Ospedale San Raffaele
- Study coordinator: Pietro Panizza, MD
- Email: panizza.pietro@hsr.it
- Phone: 00390226436310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Disease