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Study identifier: NCT04767659 Synced from ClinicalTrials.gov · July 29, 2026
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Monitoring Response to NAC and Prediction of pCR in Breast Cancer Patients Using Optical Imaging

Condition: Breast Cancer Female · Chemotherapy Effect  ·  Sponsor: IRCCS San Raffaele

PhaseNA
Planned participants20
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

Neoadjuvant chemotherapy (NAC) is the first line treatment for locally advanced breast cancer (BC). Besides making breast conserving surgery feasible, its main aim is to achieve a pathological complete response (pCR). Previous studies demonstrated that a pCR correlated with a higher disease-free survival. Tumor response may vary among different BC subtypes and only 30% of BC respond completely to NAC. Treating chemo-resistant disease with NAC may cause patient harm due to drug toxicity and surgery delay. It is therefore very important to promptly identify those women who will not benefit from NAC. Mammography and ultrasound proved ineffective in monitoring changes in lesion size due to therapy-induced fibrosis. MRI is the most accurate imaging technique for assessing early clinical response by measuring tumor size, however its accuracy is lower post NAC. This necessitates the need for a new technique able to non invasively assess the effectiveness of NAC. Optical techniques are sensitive to the biological changes that occur within the tumor after NAC administration. These changes occur prior to tumor size reduction. Optically estimated total hemoglobin concentration correlates with the histological analysis of vasculature as well as with tumor-associated angiogenesis which can affect tumor changes during NAC. Other promising biomarkers related to tissue composition (water, lipid, collagen content) and structure (scattering) may also be evaluated by optical techniques. The…

This description comes directly from the study's public registry record.

Talk to the study team

PIETRO PANIZZA, PI  ·  02-26436310  ·  panizza.pietro@hsr.it

CAROLINA SANTANGELO  ·  santangelo.carolina@hsr.it

Always discuss trial participation with your own doctor first.

Locations (1)

Ospedale San RaffaeleMilan, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT04767659