Using photoacoustic imaging to assess breast cancer and treatment response

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

This study is testing a new imaging technique to see if it can help tell the difference between harmless and cancerous breast lumps and track how tumors change during chemotherapy.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (other)
• Drugs / interventions: Chemotherapy, radiation
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT04428528 on ClinicalTrials.gov

What this trial studies

This pilot study aims to explore the use of photoacoustic imaging to differentiate between benign and malignant breast lesions and to monitor changes in breast tumors during neoadjuvant chemotherapy. The study will assess tissue characteristics at diagnosis and track physiological changes over time in patients undergoing treatment. By identifying specific photoacoustic parameters, the researchers hope to correlate these findings with pathological responses to chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 20 to 80 who are receiving neoadjuvant chemotherapy for locally advanced breast cancer.

Not a fit: Patients with significant breast abnormalities or dermatologic issues that could interfere with imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of breast cancer diagnosis and treatment monitoring, leading to better patient outcomes.

How similar studies have performed: While photoacoustic imaging is a relatively novel approach in this context, similar imaging techniques have shown promise in other studies, indicating potential for success.

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.

Where this trial is running

Toronto, Ontario

• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Gregory J Czarnota, PhD, MD — Sunnybrook Health Sciences Centre
• Study coordinator: Gregory J Czarnota, PhD, MD

Conditions: Breast Cancer, chemotherapy, photoacoustic imaging