Clinical trial NCT04428528: Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy
Official title: Pilot Study to Evaluate Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: chemotherapy
photoacoustic imaging
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: Treatment response correlation between photoacoustic parameters and histopathological measurement.
timeFrame: 4 to 8 months
Secondary outcomes:
measure: Breast mass characterization
timeFrame: 30 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Gregory J Czarnota, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: