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

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ClinicalTrials.gov Identifier: NCT04428528
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre

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.

Condition or disease
Breast Cancer

Detailed Description:
This study will investigate photoacoustic tissue characteristics of breast lesions both at diagnosis, and within a separate subgroup of patients, physiological changes in breast tumors during neoadjuvant chemotherapy (NAC). 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. Our hope is to use this information to correlate with pathological response.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Evaluate Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : February 13, 2022
Estimated Study Completion Date : February 13, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
Neoadjuvant Chemotherapy Monitoring
Breast Mass Characterization



Primary Outcome Measures :
  1. Treatment response correlation between photoacoustic parameters and histopathological measurement. [ Time Frame: 4 to 8 months ]
    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.


Secondary Outcome Measures :
  1. Breast mass characterization [ Time Frame: 30 days ]
    The secondary study endpoint will investigate if breast masses (benign vs. malignant) can be characterized by PA during clinical diagnostic work-up. Differences in the photoacoustic tissue-properties will be compared to histopathological evaluation. No diagnostic information from PA measurements will be used for patient-care/diagnosis as a result of our observations in this pilot observational study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cohort 1 - Neoadjuvant Chemotherapy Monitoring:

Men and women between 20 to 80 years of age with either a biopsy confirmed diagnosis of breast cancer and receiving neoadjuvant chemotherapy.

Cohort 2 - Breast Mass Characterization:

Men and women between 20 to 80 years of age suspected of having a mammary, benign or malignant mass and are schedule to undergo diagnostic and clinical work-up.

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+/-).

Cohort 1 - Neoadjuvant Chemotherapy Monitoring:

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.

Cohort 2 - Breast Mass Characterization:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428528


Contacts
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Contact: Gregory J Czarnota, PhD, MD (416) 480-6128 gregory.czarnota@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Gregory J Czarnota, PhD, MD    (416)480-6128    gregory.czarnota@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Gregory J Czarnota, PhD, MD Sunnybrook Health Sciences Centre
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Responsible Party: Dr. Gregory Czarnota, Radiation Oncologist and Clinical Scientist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04428528    
Other Study ID Numbers: 456-2016
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre:
chemotherapy
photoacoustic imaging
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases