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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Gregory J Czarnota, PhD, MD
gregory.czarnota@sunnybrook.ca
(416) 480-6128
Time Frame
Start Date: 2017-02-13
Estimated Completion Date: 2029-02-13
Participants
Target number of participants: 100
Treatments
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
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.
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov