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

NCT04428528 | Recruiting

• 1 other identifier: 456-2016
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

chemotherapy; photoacoustic imaging

Outcome Measures

Primary Outcomes (1)

• Treatment response correlation between photoacoustic parameters and histopathological measurement.

  The primary study endpoint will investigate changes of measured photoacoustic markers and compare to these to histopathological indicators of breast tumor response to NAC. Changes in photoacoustic parameters (hemoglobin concentration, oxygen saturation, tumor structure) 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.

  4 to 8 months

Secondary Outcomes (1)

• Breast mass characterization

  30 days

Study Arms (2)

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

Device: Photoacoustics Imaging System

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.

Device: Photoacoustics Imaging System

Interventions

Photoacoustics Imaging System DEVICE

Characterizing breast masses for photoacoustic markers measurements

Breast Mass Characterization; Neoadjuvant Chemotherapy Monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort 1 - Neoadjuvant Chemotherapy Monitoring: Men and women with either a biopsy confirmed diagnosis of breast cancer and receiving neoadjuvant chemotherapy. Cohort 2 - Breast Mass Characterization: Men and women suspected of having a mammary, benign or malignant mass and are schedule to undergo diagnostic and clinical work-up.

You may qualify if:

• 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+/-).

You may not qualify if:

• 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
• Cohort 2 - Breast Mass Characterization:
• 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.
• 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;

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gregory J Czarnota, PhD, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory J Czarnota, PhD, MD

CONTACT

(416) 480-6128; gregory.czarnota@sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist and Clinical Scientist

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: February 13, 2017
• Primary Completion: February 13, 2025
• Study Completion (Estimated): February 13, 2029
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

CA (1)