NCT04767659 Monitoring Response to NAC and Prediction of pCR in Breast Cancer Patients Using Optical Imaging
| NCT ID | NCT04767659 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2020-01-27 |
| Primary Completion | 2025-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2020-01-27 with a primary completion date of 2025-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 aim of the study is to monitor the effectiveness of NAC in BC patients with a near infrared spectroscopic imaging platform which allows to non-invasively detect changes in vascularization and size of BC and to characterize the presence of temporal changes in regional concentrations of relevant biomarkers (oxy- and deoxyhemoglobin, water, lipid and collagen concentration, scattering) within tissue during NAC. This optical imaging technique will provide a non-invasive, safe and relatively inexpensive tool to monitor patients' response to NAC and to predict their outcome.
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
Contact & Investigator
PANIZZA
PRINCIPAL INVESTIGATOR
IRCCS San Raffaele
Frequently Asked Questions
Who can join the NCT04767659 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04767659 currently recruiting?
Yes, NCT04767659 is actively recruiting participants. Contact the research team at panizza.pietro@hsr.it for enrollment information.
Where is the NCT04767659 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT04767659 clinical trial?
NCT04767659 is sponsored by IRCCS San Raffaele. The principal investigator is PANIZZA at IRCCS San Raffaele. The trial plans to enroll 20 participants.
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