Using photoacoustic imaging to assess breast cancer and treatment response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: gregory.czarnota@sunnybrook.ca
• Phone: (416) 480-6128

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.