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Use of Ultrasound Imaging and Spectroscopy as Early Indicators of Locally- Advanced Breast Cancer Response to Neoadjuvant Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04134780
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : June 18, 2020
Information provided by (Responsible Party):
Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre

Brief Summary:
This work explores the possibility of using ultrasound imaging and spectroscopy as a way of monitoring cell death, hence, tumour response to treatment. The hypothesis here is that it can be used as a way of monitoring early response to cancer treatment and predicting which patients continue on in their therapy to have a complete pathological response as a primary endpoint and tumour size decrease as a secondary endpoint. If this work is successful it could be used in the future early on in a cancer patient's treatment to predict whether or not a course of chemotherapy or radiotherapy is going to be successful. For example, in patients in which the analysis indicates a poor response the chemotherapy regimen could be changed to a more efficacious one or for those receiving radiotherapy predicted to have a poor response a radiosensitizing agent could be used to improve outcome.

Condition or disease
Breast Cancer

Detailed Description:
The primary objective in this study is to identify optimal ultrasound spectroscopy parameters that can be used as an early predictor of pathological complete or partial response in women with locally advanced breast cancer receiving treatment with chemotherapy or combined modality chemotherapy and radiotherapy. A secondary objective is to perform an inter-user variability comparison by comparing second site data analysis outcomes with central co-coordinating site data analysis. The overarching goal of this research is to transform the delivery of neoadjuvant chemotherapy using quantitative ultrasound, which is non-invasive, inexpensive and portable to assess breast cancer therapies through functional imaging, in which tumour cell death is detected. By detecting cell death early in a treatment on the order of hours to days, rather than traditional anatomical assessments that take place weeks to months after the completion of therapy, ineffective therapies could be switched to more efficacious treatments or aggressive salvage therapy which has shown to already benefit patients. This has the potential of improving survival in addition to sparing patients unnecessary side effects of treatments that may span weeks to months. The investigators will use these quantitative methods to evaluate treatments with neoadjuvant chemotherapy in women with locally advanced breast cancer. This investigation will track the spatio-temporal changes in quantitative ultrasound surrogates of treatment response during neoadjuvant chemotherapy of locally advanced breast cancer and use these parameters to adapt clinical treatment. The study specifically will expand on single- institution research underway and involve a second clinical site. Data will be independently collected and analysis carried out at that site and at the co-ordinating site for comparison evaluating technology-use feasibility and reproducibility of results.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Investigation of Ultrasound Imaging and Spectroscopy as Early Indicators of Locally- Advanced Breast Cancer Response to Neoadjuvant Treatment
Actual Study Start Date : August 2014
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Breast Characterization

Primary Outcome Measures :
  1. Measuring the rate of treatment response between the treatment groups [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Inter-user variability comparison [ Time Frame: Up to 5 years ]
    comparing second site data analysis outcomes with central co-coordinating site data analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Both men and women and members of all races and ethnic groups are eligible for this trial.

Inclusion Criteria:

  1. Histologically or cytologically confirmed locally advanced breast carcinoma which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy
  2. Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment
  3. Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1
  4. Life expectancy of at least 6 months
  5. 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

Exclusion Criteria:

  1. History of allergic reactions attributed to compounds of similar chemical or biologic composition
  2. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
  3. Psychiatric illness/social situations that would limit compliance with study requirements
  4. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in 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 identifier (NCT number): NCT04134780

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Contact: Gregory J Czarnota, PhD, MD (416) 480-6128

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United States, Texas
MD Anderson Completed
Houston, Texas, United States, 77030
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Gregory J Czarnota, PhD, MD    (416) 480-6128   
Princess Margaret Cancer Centre Completed
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Responsible Party: Dr. Gregory Czarnota, Radiation Oncologist and Clinician Scientist, Sunnybrook Health Sciences Centre Identifier: NCT04134780    
Other Study ID Numbers: 301-2014
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: June 18, 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:
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases