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Recruiting NCT04428528

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

— Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Photoacoustics Imaging System.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Device Photoacoustics Imaging System
    Characterizing breast masses for photoacoustic markers measurements

Primary outcome measures

  • Treatment response correlation between photoacoustic parameters and histopathological measurement. [Time frame: 4 to 8 months]
Secondary outcome measures (1)
  • Breast mass characterization [Time frame: 30 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Sunnybrook Health Sciences Centre — Toronto

Identifiers

NCT: NCT04428528 · 456-2016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗