Monitoring Response to NAC and Prediction of pCR in Breast Cancer Patients Using Optical Imaging

NCT04767659 | Recruiting DMC

• 1 other identifier: NADOPTIC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female; Chemotherapy Effect

Keywords

Neoadjuvant chemotherapy; Pathological complete response; Optical imaging

Outcome Measures

Primary Outcomes (2)

• Optical monitoring of neoadjuvant chemotherapy in breast cancer patients

  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

  Optical data will be evaluated to distinguish responders from non responders

  The through completion study is that of an average of 1 year

Study Arms (1)

Women candidate for clinical trial

EXPERIMENTAL

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).

Device: MAMMOT2

Interventions

MAMMOT2 DEVICE

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.

Women candidate for clinical trial

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women above 18 years of age
• Women with a recent diagnosis of breast cancer candidate for neoadjuvant chemotherapy
• Women willing to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Politecnico di Milano: collaborator

Study Sites (1)

Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (13)

• 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.

  PMID: 25121479 BACKGROUND

• 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.

  PMID: 23117178 BACKGROUND

• 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.

  PMID: 25615743 BACKGROUND

• 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.

  PMID: 26778289 BACKGROUND

• 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.

  PMID: 26120204 BACKGROUND

• 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.

  PMID: 17468951 BACKGROUND

• 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.

  PMID: 19724592 BACKGROUND

• 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.

  PMID: 29552410 BACKGROUND

• 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.

  PMID: 25360382 BACKGROUND

• 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.

  PMID: 23804215 BACKGROUND

• 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.

  PMID: 28091596 BACKGROUND

• 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.

  PMID: 23224161 BACKGROUND

• 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.

  PMID: 23296038 BACKGROUND

Study Officials

• PANIZZA

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PIETRO PANIZZA, PI

CONTACT

02-26436310; panizza.pietro@hsr.it

CAROLINA SANTANGELO

CONTACT

santangelo.carolina@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Breast Imaging Unit, MD

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: February 23, 2021
• Study Start: January 27, 2020
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IT (1)