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

NCT ID: NCT04428528

Last Updated: 2023-12-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-13
• Study Completion Date: 2029-02-13

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.

Conditions

Breast Cancer

Keywords

chemotherapy; photoacoustic imaging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Photoacoustics Imaging System

Intervention Type: DEVICE

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.

Photoacoustics Imaging System

Intervention Type: DEVICE

Characterizing breast masses for photoacoustic markers measurements

Interventions

Photoacoustics Imaging System

Characterizing breast masses for photoacoustic markers measurements

Intervention Type: DEVICE

Eligibility Criteria

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+/-).

• 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.

Cohort 2 - Breast Mass Characterization:

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Gregory Czarnota

Radiation Oncologist and Clinical Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory J Czarnota, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Gregory J Czarnota, PhD, MD

Role: CONTACT

Phone: (416) 480-6128

Email: gregory.czarnota@sunnybrook.ca

Facility Contacts

Gregory J Czarnota, PhD, MD

Role: primary

Other Identifiers

456-2016

Identifier Type: -

Identifier Source: org_study_id