Clinical trial · Interventional
Monitoring Response to NAC and Prediction of pCR in Breast Cancer Patients Using Optical Imaging
Optical Monitoring of Neoadjuvant Chemotherapy and Prediction of Pathological Complete Response in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Chemotherapy Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MAMMOT2 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Women candidate for clinical trial
- description
- Twenty adult women with a recent diagnosis of breast cancer, candidate for NAC, besides assessing the response to neoadjuvant chemotherapy using standard imaging evaluation, will undergo optical imaging at six selected time points from prior to commencement of NAC/baseline to the completion of NAC treatment (prior to surgery).
- interventionNames
- Device: MAMMOT2
Primary outcomes (2)
- measure
- Optical monitoring of neoadjuvant chemotherapy in breast cancer patients
- timeFrame
- The through completion study is that of an average of 1 year
- description
- Optical data will be compared to the conventional imaging results and to the surgical specimen histology (gold standard)
- measure
- Prediction of pathological complete response to neoadjuvant chemotherapy using optical imaging
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (13)
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- BACKGROUNDDurduran T, Choe R, Baker WB, Yodh AG. Diffuse Optics for Tissue Monitoring and Tomography. Rep Prog Phys. 2010 Jul;73(7):076701. doi: 10.1088/0034-4885/73/7/076701. PMID 26120204
- BACKGROUNDLeff DR, Warren OJ, Enfield LC, Gibson A, Athanasiou T, Patten DK, Hebden J, Yang GZ, Darzi A. Diffuse optical imaging of the healthy and diseased breast: a systematic review. Breast Cancer Res Treat. 2008 Mar;108(1):9-22. doi: 10.1007/s10549-007-9582-z. Epub 2007 Apr 28. PMID 17468951
- BACKGROUNDTaroni P, Pifferi A, Salvagnini E, Spinelli L, Torricelli A, Cubeddu R. Seven-wavelength time-resolved optical mammography extending beyond 1000 nm for breast collagen quantification. Opt Express. 2009 Aug 31;17(18):15932-46. doi: 10.1364/OE.17.015932.