Breast CancerNCT04428528
Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy
An observational study of Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Photoacoustics Imaging System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 13 Feb 2017to 13 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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;
Show all 9Show fewer
- 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 join
- 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;
Show all 19Show fewer
- 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:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Gregory J Czarnota, PhD, MD, (416)480-6128, gregory.czarnota@sunnybrook.ca
About this study
Official title: Pilot Study to Evaluate Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Photoacoustics Imaging System
- Keywords
- chemotherapy, photoacoustic imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoacoustics Imaging SystemDevice
Characterizing breast masses for photoacoustic markers measurements
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Photoacoustics Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 to 8 months
Secondary outcomes (1)
Breast mass characterization
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start13 Feb 2017
- Primary completion13 Feb 2025 (estimated)
- Study completion13 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre
- Investigators
- Gregory J Czarnota, PhD, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428528
- Sponsor's protocol ID
- 456-2016
- Status last verified
- Dec 2023
- First submitted
- 9 Jun 2020
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04428528
- Acronym / sponsor ID
- 456-2016
- Conditions
- Breast Cancer
- Keywords
- chemotherapy, photoacoustic imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 13 Feb 2025 (estimated)
- Study completion
- 13 Feb 2029 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemotherapy Monitoring | – | Device: Photoacoustics Imaging SystemThe 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 | – | Device: Photoacoustics Imaging SystemThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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+/-).
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photoacoustics Imaging SystemCharacterizing breast masses for photoacoustic markers measurements | Device | Breast Mass Characterization, Neoadjuvant Chemotherapy Monitoring |
Primary outcome
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.
1 secondary outcome
Breast mass characterization
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory J Czarnota, PhD, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory J Czarnota, PhD, MD ((416) 480-6128, gregory.czarnota@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response correlation between photoacoustic parameters and histopathological measurement. (time frame: 4 to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.