- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04767659
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this study, an accurate, reliable, non-invasive modality with good patient tolerance will be tested to predict response to NAC in order to tailor the medical and surgical treatment.
The aim of this project is to monitor the effectiveness of NAC in BC patients with a new near infrared spectroscopic imaging platform which allows to non-invasively detect changes in size, vascularization and blood oxygenation in tumors and to characterize the presence of temporal changes in regional concentrations of relevant biomarkers like oxy- and deoxyhemoglobin, water, lipid and collagen and scattering in the tissue during NAC. This optical imaging tool will allow a non-invasive, safe and relatively inexpensive monitoring of NAC and prediction of patients' outcome.
A single-site, national, non-comparative, non-randomized study will be conducted at the San Raffaele Hospital in Milan in collaboration with the Politecnico di Milano. The medical device is a prototype developed by Politecnico di Milano.
Twenty adult women with a recent diagnosis of breast cancer and candidate for NAC, who fulfil the inclusion criteria and agree to voluntary participate in the study under informed consent, will be enrolled.
Besides assessing the response to neoadjuvant chemotherapy using conventional imaging evaluation (x-ray mammography and breast ultrasound prior to commencement/baseline, half way through and on completion of NAC; contrast-enhanced MRI prior to commencement/baseline and on completion of NAC), the patients enrolled will be evaluated with optical imaging at the following six selected time points (prior to commencement of NAC/baseline, 2-5 days post-NAC, 6-8 days post-NAC, 2 weeks post-NAC, half-way through and on completion of NAC).
A preliminary phase will be performed on the first 5 patients out of the 20 patients enrolled, in order to evaluate the potential artefacts related to a recent breast biopsy and to the positioning of a clip. In this preliminary phase, 2 additional optical evaluations will be carried out, one prior to the breast biopsy and one after the positioning of the clip.
Patients are enrolled in the study for the entire duration of NAC. No follow-up is required and patients will be followed according to the regular clinical standard of care. Moreover, the outcome of the optical investigation does not affect the treatment and management of the women enrolled in the study.
The duration of enrolment of the study is expected to be approximately 12 months. The study will end when the last patient enrolled will complete her chemotherapy treatment.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: PIETRO PANIZZA, PI
- Phone Number: 02-26436310
- Email: panizza.pietro@hsr.it
Study Contact Backup
- Name: CAROLINA SANTANGELO
- Email: santangelo.carolina@hsr.it
Study Locations
-
-
-
Milano, Italy, 20132
- Recruiting
- Ospedale San Raffaele
-
Contact:
- PIETRO PANIZZA
- Email: panizza.pietro@hsr.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Women candidate for clinical trial
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).
|
Breast cancer patients candidate for neoadjuvant chemotherapy will be evaluated with optical imaging prior to commencement of NAC/baseline, 2-5 days post-NAC, 6-8 days post-NAC, 2 weeks post-NAC, half-way through and on completion of NAC. 2 additional optical evaluations will be carried out on the first 5 patients enrolled, one before breast biopsy and one after the positioning of the metallic clip, in order to evaluate the potential artefacts related to these procedures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optical monitoring of neoadjuvant chemotherapy in breast cancer patients
Time Frame: The through completion study is that of an average of 1 year
|
Optical data will be compared to the conventional imaging results and to the surgical specimen histology (gold standard)
|
The through completion study is that of an average of 1 year
|
Prediction of pathological complete response to neoadjuvant chemotherapy using optical imaging
Time Frame: The through completion study is that of an average of 1 year
|
Optical data will be evaluated to distinguish responders from non responders
|
The through completion study is that of an average of 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: PANIZZA, IRCCS San Raffaele
Publications and helpful links
General Publications
- Wabnitz H, Taubert DR, Mazurenka M, Steinkellner O, Jelzow A, Macdonald R, Milej D, Sawosz P, Kacprzak M, Liebert A, Cooper R, Hebden J, Pifferi A, Farina A, Bargigia I, Contini D, Caffini M, Zucchelli L, Spinelli L, Cubeddu R, Torricelli A. Performance assessment of time-domain optical brain imagers, part 1: basic instrumental performance protocol. J Biomed Opt. 2014 Aug;19(8):086010. doi: 10.1117/1.JBO.19.8.086010.
- Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast cancer screening: an independent review. Lancet. 2012 Nov 17;380(9855):1778-86. doi: 10.1016/S0140-6736(12)61611-0. Epub 2012 Oct 30.
- Brem RF, Lenihan MJ, Lieberman J, Torrente J. Screening breast ultrasound: past, present, and future. AJR Am J Roentgenol. 2015 Feb;204(2):234-40. doi: 10.2214/AJR.13.12072.
- Liu B, Zheng Y, Huang G, Lin M, Shan Q, Lu Y, Tian W, Xie X. Breast Lesions: Quantitative Diagnosis Using Ultrasound Shear Wave Elastography-A Systematic Review and Meta--Analysis. Ultrasound Med Biol. 2016 Apr;42(4):835-47. doi: 10.1016/j.ultrasmedbio.2015.10.024. Epub 2016 Jan 6.
- Durduran 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.
- Leff 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.
- Taroni 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.
- Ferocino E, Martinenghi E, Dalla Mora A, Pifferi A, Cubeddu R, Taroni P. High throughput detection chain for time domain optical mammography. Biomed Opt Express. 2018 Jan 23;9(2):755-770. doi: 10.1364/BOE.9.000755. eCollection 2018 Feb 1.
- Quarto G, Spinelli L, Pifferi A, Torricelli A, Cubeddu R, Abbate F, Balestreri N, Menna S, Cassano E, Taroni P. Estimate of tissue composition in malignant and benign breast lesions by time-domain optical mammography. Biomed Opt Express. 2014 Sep 18;5(10):3684-98. doi: 10.1364/BOE.5.003684. eCollection 2014 Oct 1.
- Taroni P, Quarto G, Pifferi A, Ieva F, Paganoni AM, Abbate F, Balestreri N, Menna S, Cassano E, Cubeddu R. Optical identification of subjects at high risk for developing breast cancer. J Biomed Opt. 2013 Jun;18(6):060507. doi: 10.1117/1.JBO.18.6.060507.
- Taroni P, Paganoni AM, Ieva F, Pifferi A, Quarto G, Abbate F, Cassano E, Cubeddu R. Non-invasive optical estimate of tissue composition to differentiate malignant from benign breast lesions: A pilot study. Sci Rep. 2017 Jan 16;7:40683. doi: 10.1038/srep40683.
- Pearlman PC, Adams A, Elias SG, Mali WP, Viergever MA, Pluim JP. Mono- and multimodal registration of optical breast images. J Biomed Opt. 2012 Aug;17(8):080901-1. doi: 10.1117/1.JBO.17.8.080901.
- Tavakoli B, Zhu Q. Two-step reconstruction method using global optimization and conjugate gradient for ultrasound-guided diffuse optical tomography. J Biomed Opt. 2013 Jan;18(1):16006. doi: 10.1117/1.JBO.18.1.016006.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NADOPTIC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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