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

Sunnybrook Health Sciences Centre

Status: Enrolling

Conditions: Breast Cancer

Treatments: Device: Photoacoustics Imaging System

Study type: Observational

Funder types: Other

Identifiers

NCT04428528

456-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

100 participants in 2 patient groups

Neoadjuvant Chemotherapy Monitoring

Description:

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

Treatment:

Device: Photoacoustics Imaging System

Breast Mass Characterization

Description:

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.

Treatment:

Device: Photoacoustics Imaging System