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Search / Trial NCT04767659

Monitoring Response to NAC and Prediction of pCR in Breast Cancer Patients Using Optical Imaging

Launched by IRCCS SAN RAFFAELE · Feb 22, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Neoadjuvant Chemotherapy Pathological Complete Response Optical Imaging

ClinConnect Summary

This clinical trial is studying a new way to monitor how well neoadjuvant chemotherapy (NAC) is working in women with locally advanced breast cancer. NAC is often the first treatment given to shrink tumors before surgery, and the goal is to achieve a complete response, which means no signs of cancer are left. Unfortunately, about 70% of patients do not respond fully to this treatment, and it’s important to identify these women early to avoid unnecessary side effects and delays in surgery. The trial is testing a special imaging technique that uses light to look at changes in the tumor's blood flow and other important features during chemotherapy, which can help predict how well the treatment is working.

To be eligible for this trial, women must be over 18 years old, newly diagnosed with breast cancer, and willing to provide consent to participate. However, individuals who are pregnant, have had previous surgery on the same breast, or have cancer that has spread to other parts of the body cannot participate. If you join this trial, you can expect to undergo non-invasive imaging tests that will help doctors monitor your response to chemotherapy without the need for more invasive procedures. This approach aims to provide a safer and more effective way to manage treatment for breast cancer patients.

Gender

FEMALE

Eligibility 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

About Irccs San Raffaele

IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.

Locations

Milano, , Italy

Patients applied

0 patients applied

Trial Officials

PANIZZA

Principal Investigator

IRCCS San Raffaele

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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