Photoacoustic Imaging for Characterizing Breast Masses an... | NCT04428528

NCT04428528

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Photoacoustics Imaging System	Device	Characterizing breast masses for photoacoustic markers measurements	Breast Mass Characterization Neoadjuvant Chemotherapy Monitoring

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

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.