Optical Imaging for Breast Cancer Chemotherapy Response
Monitoring Response to NAC and Prediction of pCR in Breast Cancer Patients Using Optical Imaging
Recruiting
N/AInterventional Study
Breast Cancer FemaleChemotherapy Effect
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Diagnostic
Participants needed
20 (estimated)
Sponsor
IRCCS San Raffaele · Other
Who this trial is looking for
This trial is looking for women over 18 who have been diagnosed with breast cancer and are planning to start chemotherapy. Participants will help researchers find better ways to monitor treatment response using optical imaging technology.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I have been diagnosed with breast cancer.
I am a candidate for neoadjuvant chemotherapy.
I am willing to give informed consent.
You may not be able to join if
I am pregnant or breastfeeding.
I cannot or do not want to give informed consent.
I have had previous surgery on the same breast.
I have breast implants.
I have distant metastasis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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
*…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.