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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04428528
• Other study ID #: 456-2016
• Status: Recruiting
• Start date: February 13, 2017
• Est. completion date: February 13, 2029

Study information

• Verified date: December 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Gregory J Czarnota, PhD, MD
• Phone: (416) 480-6128
• Email: gregory.czarnota[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 13, 2029
• Est. primary completion date: February 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Photoacoustics Imaging System
Characterizing breast masses for photoacoustic markers measurements

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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