Breast Cancer InvasiveNCT00437879
Ultrasound Imaging, Spectroscopy and Ultrasound Imaging of Vascular Blood Flow as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment.
An observational study of Breast Cancer Invasive, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
We have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer Invasive
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- 17 Dec 2008to Jun 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who are receiving neoadjuvant chemotherapy or neoadjuvant chemo-radiotherapy for breast cancer.
Who may be able to join
- The following criteria are necessary for study participation:
- Histologically or cytologically confirmed breast carcinoma, stage I-IV, which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy.
- Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment.
- Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1.
- Life expectancy of at least 6 months.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory. Requirements to be conducted within 7 days prior to dosing:
- hemoglobin >90 mg/dL (ii) leukocytes >3,000/mL (iii) absolute neutrophil count >1,500/mL (iv) platelets >100,000/mL (v) total bilirubin within normal institutional limits (vi) AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal (vii) creatinine within normal institutional limits or creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal
- Patients should have the ability to understand and the willingness to sign a written informed consent document. Signed informed consent must be obtained prior to any study specific procedures.
Who cannot join
- The following conditions will exclude women from participation:
- Chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration.
- Receiving any other investigational agents.
- Known brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition.
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, M4N 3M5
About this study
Official title: Pilot Investigation of Ultrasound Imaging and Spectroscopy and Ultrasound Imaging of Vascular Blood Flow as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment
We have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. The method can detect different forms of cell death and has been demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. The objectives of this study are to evaluate the use of ultrasound imaging and spectroscopy as a predictive marker of advanced tumour response to combined chemotherapy and radiotherapy. Since neoadjuvant treatments may also act on tumour vasculature to "normalize" it we will also evaluate blood-vessel imaging by standard Doppler-imaging and with standard higher-resolution imaging using clinically approved microbubble contrast agents.
The main goal, as described above, is to select the best ultrasound spectroscopy parameter to use as an early predictor of pathological complete response.
Read the detailed description
We have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. The method can detect different forms of cell death and has been demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. The objectives of this study are to evaluate the use of ultrasound imaging and spectroscopy as a predictive marker of advanced tumour response to combined chemotherapy and radiotherapy. Since neoadjuvant treatments may also act on tumour vasculature to "normalize" it we will also evaluate blood-vessel imaging by standard Doppler-imaging and with standard higher-resolution imaging using clinically approved microbubble contrast agents.
The main goal, as described above, is to select the best ultrasound spectroscopy parameter to use as an early predictor of pathological complete response.
Specifically, we will as a primary endpoint correlate changes in ultrasound backscatter parameters obtained throughout the course of treatment with pathological complete, partial, or complete and partial response. We ultimately hope to be able to generate a Receiver-Operator-Curve for each parameter beyond this pilot investigation. The ultrasound-spectroscopy parameters to be examined include mid-band fit, spectral-slope and histogram-distribution-fit parameters related to scatterer size and concentration. From these various receiver-operator curves the best ultrasound parameter for predicting response will be selected and will aid to define the clinical specificity and sensitivity of the technique.
The secondary endpoint in this study will include examining the change in size of the tumour, which will also be measured using conventional gold-standard B-scan ultrasound imaging (length by width by height in addition to volume) and correlating that to the spectroscopic ultrasound changes determined at different times during patient treatment.
Other secondary endpoints will include measuring changes in blood vessel distribution by standard Doppler-imaging and standard microbubble contrast agent imaging. As another secondary endpoint we will also correlate our ultrasound changes with 2 and 5-year long-term clinical outcome.
- Conditions
- Breast Cancer Invasive
- Keywords
- Breast Cancer, Ultrasound, Neoadjuvant Treatment
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary Outcome will be correlate changes in ultrasound backscatter parameters obtained throughout the course of treatment with pathological complete, partial, or complete and partial response.
Ultrasound spectroscopy parameters to be examined include mid-band fit parameters, spectral slope and histogram distribution fit parameters related to scatterer size and concentration. From these various receiver-operator curves, the best ultrasound parameter predictive response will be selected and will aid to define the clinical specificity and sensitivity of The technique.
Measured: 2 and 5-year long-term clinical outcome
Secondary outcomes (2)
The secondary Outcome of this study will include examining the change in tumor size.
The change in tumor size, which It will also be measured using conventional gold standard B-scan ultrasound images (length by width by height in addition to volume) and correlating it with spectroscopic ultrasound changes determined at different times during the patient's treatment.
Measured: 2 and 5-year long-term clinical outcome
Other secondary Outcome will include measuring changes in the blood vessels distribution in the tumor.
Measurement of changes in the distribution of blood vessels according to the standard doppler-imaging and standard microbubbles contrast agent imaging.
Measured: 2 and 5-year long-term clinical outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study start17 Dec 2008
- Primary completionJun 2027 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer InvasiveStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 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, Ph.D. M.D., Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437879
- Sponsor's protocol ID
- 185-2006
- Status last verified
- Dec 2023
- First submitted
- 20 Feb 2007
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Investigation of Ultrasound Imaging and Spectroscopy and Ultrasound Imaging of Vascular Blood Flow as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment
- ClinicalTrials.gov ID
- NCT00437879
- Acronym / sponsor ID
- 185-2006
- Conditions
- Breast Cancer Invasive
- Keywords
- Breast Cancer, Ultrasound, Neoadjuvant Treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 17 Dec 2008 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 21 Feb 2007 (estimated)
- 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.
We have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. The method can detect different forms of cell death and has been demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. The objectives of this study are to evaluate the use of ultrasound imaging and spectroscopy as a predictive marker of advanced tumour response to combined chemotherapy and radiotherapy. Since neoadjuvant treatments may also act on tumour vasculature to "normalize" it we will also evaluate blood-vessel imaging by standard Doppler-imaging and with standard higher-resolution imaging using clinically approved microbubble contrast agents.
The main goal, as described above, is to select the best ultrasound spectroscopy parameter to use as an early predictor of pathological complete response.
Detailed description
We have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. The method can detect different forms of cell death and has been demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. The objectives of this study are to evaluate the use of ultrasound imaging and spectroscopy as a predictive marker of advanced tumour response to combined chemotherapy and radiotherapy. Since neoadjuvant treatments may also act on tumour vasculature to "normalize" it we will also evaluate blood-vessel imaging by standard Doppler-imaging and with standard higher-resolution imaging using clinically approved microbubble contrast agents.
The main goal, as described above, is to select the best ultrasound spectroscopy parameter to use as an early predictor of pathological complete response.
Specifically, we will as a primary endpoint correlate changes in ultrasound backscatter parameters obtained throughout the course of treatment with pathological complete, partial, or complete and partial response. We ultimately hope to be able to generate a Receiver-Operator-Curve for each parameter beyond this pilot investigation. The ultrasound-spectroscopy parameters to be examined include mid-band fit, spectral-slope and histogram-distribution-fit parameters related to scatterer size and concentration. From these various receiver-operator curves the best ultrasound parameter for predicting response will be selected and will aid to define the clinical specificity and sensitivity of the technique.
The secondary endpoint in this study will include examining the change in size of the tumour, which will also be measured using conventional gold-standard B-scan ultrasound imaging (length by width by height in addition to volume) and correlating that to the spectroscopic ultrasound changes determined at different times during patient treatment.
Other secondary endpoints will include measuring changes in blood vessel distribution by standard Doppler-imaging and standard microbubble contrast agent imaging. As another secondary endpoint we will also correlate our ultrasound changes with 2 and 5-year long-term clinical outcome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who are receiving neoadjuvant chemotherapy or neoadjuvant chemo-radiotherapy for breast cancer.
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed breast carcinoma, stage I-IV, which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy.
- Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment.
- Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1.
- Life expectancy of at least 6 months.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory. Requirements to be conducted within 7 days prior to dosing:
Key exclusion criteria (5 listed)
- Chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration.
- Receiving any other investigational agents.
- Known brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary Outcome will be correlate changes in ultrasound backscatter parameters obtained throughout the course of treatment with pathological complete, partial, or complete and partial response.
Time frame: 2 and 5-year long-term clinical outcome
Ultrasound spectroscopy parameters to be examined include mid-band fit parameters, spectral slope and histogram distribution fit parameters related to scatterer size and concentration. From these various receiver-operator curves, the best ultrasound parameter predictive response will be selected and will aid to define the clinical specificity and sensitivity of The technique.
2 secondary outcomes
The secondary Outcome of this study will include examining the change in tumor size.
Time frame: 2 and 5-year long-term clinical outcome
Other secondary Outcome will include measuring changes in the blood vessels distribution in the tumor.
Time frame: 2 and 5-year long-term clinical outcome
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 12 Dec 2023.
Related trials for Breast Cancer Invasive
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Breast Cancer Invasive, Early-stage Breast Cancer
RecruitingObservational study
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
Lobular Breast Carcinoma
RecruitingPhase 2
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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, Ph.D. M.D. 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 Invasive, 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 8 inclusion and 5 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 12 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 (416-480-5329, Gregory.Czarnota@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary Outcome will be correlate changes in ultrasound backscatter parameters obtained throughout the course of treatment with pathological complete, partial, or complete and partial response. (time frame: 2 and 5-year long-term clinical outcome). 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 12 Dec 2023.