Pilot Study to Evaluate Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy Pilot Study to Evaluate Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy

STATUS

Recruiting
participants needed

100
sponsor

Sunnybrook Health Sciences Centre

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Updated on 19 February 2024

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advanced breast cancer

locally advanced breast cancer

HER2

breast neoplasm

breast mass

Summary

Our objective in this pilot study will be to identify PA parameters that can distinguish benign vs. malignant lesions, and also, if PA parameters change with within breast tumors during chemotherapy treatment over time.

Description

This study will investigate photoacoustic tissue characteristics of breast lesions both at diagnosis, and within a separate subgroup of patients, physiological changes in breast tumors during neoadjuvant chemotherapy (NAC). Our objective in this pilot study will be to identify PA parameters that can distinguish benign vs. malignant lesions, and also, if PA parameters change with within breast tumors during chemotherapy treatment over time. Our hope is to use this information to correlate with pathological response.

Details

Condition	Breast Cancer, Breast Cancer
Age	20-80 years
Clinical Study Identifier	NCT04428528
Sponsor	Sunnybrook Health Sciences Centre
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Subjects must give appropriate written informed consent prior to participation in the study
	Subjects must be able and willing to comply with the safety procedures during the Scanning Period
	Subjects must be men and women of between 20 to 80 years of age, inclusive, on the day the Informed Consent Form is signed
	Subjects must be referred to breast diagnostic clinic for investigation of a breast mass
	Cohort 2 - Breast Mass Characterization
Exclusion Criteria
	Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g.,silicone/saline implants) involving either breast, exclusive of the lesion at issue
	Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast
	Subjects with a current or past medical history of connective tissue disease
	Subjects who are pregnant or lactating
	Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator
	Subjects with a history or expectation of significant anxiety associated with undergoing diagnostic evaluations
	Subjects with a history of musculoskeletal disease which may predispose them to discomfort during the Scanning Period
	Subjects with a known sensitivity to low-power infrared radiation (e.g., as a result of a dermatologic condition); and
	Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study

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Pilot Study to Evaluate Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy Pilot Study to Evaluate Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy