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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Photoacoustics Imaging System

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Gregory J Czarnota, PhD, MD; Phone Number: (416) 480-6128; Email: gregory.czarnota@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Gregory J Czarnota, PhD, MD; Phone Number: (416)480-6128; Email: gregory.czarnota@sunnybrook.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cohort 1 - Neoadjuvant Chemotherapy Monitoring:

Men and women with either a biopsy confirmed diagnosis of breast cancer and receiving neoadjuvant chemotherapy.

Cohort 2 - Breast Mass Characterization:

Men and women suspected of having a mammary, benign or malignant mass and are schedule to undergo diagnostic and clinical work-up.

Description

Cohort 1 - Neoadjuvant Chemotherapy Monitoring:

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 receiving neoadjuvant chemotherapy for locally-advanced breast cancer.
• Biopsy-confirmed diagnosis of locally advanced breast cancer; of all molecular subtypes (ER+/-, PR+/-, HER2+/-).

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.

Cohort 2 - Breast Mass Characterization:

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.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neoadjuvant Chemotherapy Monitoring; The first arm Neoadjuvant Chemotherapy Monitoring will investigate changes of measured photoacoustic markers and compare to these to histopathological indicators of breast tumor response to NAC. Changes in photoacoustic parameters will be made to a pre-treatment point over the course of treatment. Treatment will not be modified on the basis of our observations. in this pilot observational study	Device: Photoacoustics Imaging System; Characterizing breast masses for photoacoustic markers measurements
Breast Mass Characterization; The second arm Breast Mass Characterization will investigate if breast masses (benign vs. malignant) can be characterized during clinical diagnostic work-up. Differences in the photoacoustic tissue-properties will be compared to histopathological evaluation.	Device: Photoacoustics Imaging System; Characterizing breast masses for photoacoustic markers measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response correlation between photoacoustic parameters and histopathological measurement.	The primary study endpoint will investigate changes of measured photoacoustic markers and compare to these to histopathological indicators of breast tumor response to NAC. Changes in photoacoustic parameters (hemoglobin concentration, oxygen saturation, tumor structure) will be made to a pre-treatment point over the course of treatment. Treatment will not be modified on the basis of our observations in this pilot observational study.	4 to 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast mass characterization	The secondary study endpoint will investigate if breast masses (benign vs. malignant) can be characterized by PA during clinical diagnostic work-up. Differences in the photoacoustic tissue-properties will be compared to histopathological evaluation. No diagnostic information from PA measurements will be used for patient-care/diagnosis as a result of our observations in this pilot observational study	30 days

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Gregory J Czarnota, PhD, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Estimated): February 13, 2025
• Study Completion (Estimated): February 13, 2029

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: chemotherapy; photoacoustic imaging
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 456-2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No