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Imaging Breast Masses With Light and Sound During Chemotherapy

Tests a photoacoustic imaging device in women with breast masses and breast cancer.

Key facts

Who runs it
Sunnybrook Health Sciences Centre
Where
Toronto, CanadaSee the site
Trial code
Registry title
Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy
Status
Recruiting
People taking part
100 people, planned
Started
13 Feb 2017
Expected to end
13 Feb 2029
Type of study
Observational, 2 groups
Treatments tested
  • Photoacoustics Imaging System
Record updated
13 December 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a breast mass sent for diagnosis, or with locally advanced breast cancer getting chemotherapy before surgery. It tests a photoacoustic scan.

Age
20 to 80 years old, inclusive.
Sex
Men and women can join.
Disease stage
Group 1: biopsy-confirmed locally advanced breast cancer, all molecular subtypes (ER+/-, PR+/-, HER2+/-). Group 2: a breast mass being checked at a breast diagnostic clinic.
Earlier treatment
Group 1: must be receiving neoadjuvant chemotherapy for locally advanced breast cancer.

Main reasons for not taking part

  • Past abnormalities, significant injury or procedures (for example implants) involving either breast, apart from the lesion being studied
  • Skin problems on either breast, including tattoos, open sores or breached skin
  • Connective tissue disease, now or in the past
  • Pregnant or breastfeeding
  • Implanted electronic device such as a pacemaker, defibrillator or neurological stimulator

The registry criteria, word for word

Show all 28 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 a current or past medical history of connective tissue disease
  • Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator
  • 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 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 a current or past medical history of connective tissue disease
  • Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator
  • 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 with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast
  • Subjects who are pregnant or lactating
  • Subjects with a history or expectation of significant anxiety associated with undergoing diagnostic evaluations
  • 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:
  • Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast
  • Subjects who are pregnant or lactating
  • Subjects with a history or expectation of significant anxiety associated with undergoing diagnostic evaluations
  • Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study

Other criteria

  • Cohort 1 - Neoadjuvant Chemotherapy Monitoring:

Where in Canada

  • Sunnybrook Health Sciences CentreToronto, CanadaContact: Gregory J Czarnota, PhD, MDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • 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

    Treatment: 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.

    Treatment: Photoacoustics Imaging System

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Pilot Study to Evaluate Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy
Plain-language title
Imaging Breast Masses With Light and Sound During ChemotherapyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
13 December 2023