NCT04428528 Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy
| NCT ID | NCT04428528 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2017-02-13 |
| Primary Completion | 2025-02-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2017-02-13 with a primary completion date of 2025-02-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Gregory J Czarnota, PhD, MD
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT04428528 clinical trial?
This trial is open to participants of all sexes, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04428528 currently recruiting?
Yes, NCT04428528 is actively recruiting participants. Contact the research team at gregory.czarnota@sunnybrook.ca for enrollment information.
Where is the NCT04428528 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04428528 clinical trial?
NCT04428528 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Gregory J Czarnota, PhD, MD at Sunnybrook Health Sciences Centre. The trial plans to enroll 100 participants.
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