Using optical imaging to monitor breast cancer treatment response

Optical Monitoring of Neoadjuvant Chemotherapy and Prediction of Pathological Complete Response in Breast Cancer Patients

Not applicable Interventional IRCCS San Raffaele · NCT04767659

This study is testing a new imaging method to see how well chemotherapy is working for women with breast cancer, so doctors can adjust treatments if needed.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment20 (estimated)
Ages18 Years and up
SexFemale
SponsorIRCCS San Raffaele Academic / other
Drugs / interventionschemotherapy
Locations1 site (Milan)
Trial IDNCT04767659 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate a new optical imaging technique to monitor the effectiveness of neoadjuvant chemotherapy (NAC) in women with breast cancer. The approach involves using near-infrared spectroscopic imaging to non-invasively assess changes in tumor size, vascularization, and blood oxygenation during treatment. By identifying patients who do not respond to NAC early on, the study seeks to tailor medical and surgical interventions more effectively. The trial will enroll twenty adult women diagnosed with breast cancer who are candidates for NAC at the San Raffaele Hospital in Milan.

Who should consider this trial

Good fit: Ideal candidates for this study are women over 18 years old with a recent diagnosis of breast cancer who are eligible for neoadjuvant chemotherapy.

Not a fit: Patients who are pregnant, breastfeeding, or have distant metastasis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment plans for breast cancer patients, reducing unnecessary exposure to ineffective chemotherapy.

How similar studies have performed: While there have been studies using imaging techniques in breast cancer treatment, this specific optical imaging approach is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Women above 18 years of age
* Women with a recent diagnosis of breast cancer candidate for neoadjuvant chemotherapy
* Women willing to give informed consent

Exclusion Criteria:

* Subject is pregnant or breastfeeding
* Subject is unable or unwilling to give informed consent
* Previous surgery of the same breast
* Presence of distant metastasis
* Breast implants

Where this trial is running

Milan

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Breast Cancer FemaleChemotherapy EffectNeoadjuvant chemotherapyPathological complete responseOptical imaging
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.