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Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer

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.
 
ClinicalTrials.gov Identifier: NCT04050228
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE July 22, 2019
First Posted Date  ICMJE August 8, 2019
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE June 13, 2018
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
Measuring the rate of treatment response between the treatment groups [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer
Official Title  ICMJE A Phase 2 Study of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer
Brief Summary The primary objective of this study is to assess the feasibility of randomizing breast cancer patients to quantitative ultrasound to guide adaptive Neoadjuvant Chemotherapy as compared to standard clinical monitoring and therapy. The Investigators 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. 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. The overarching goal of this research is to transform the delivery of neoadjuvant chemotherapy using quantitative ultrasound (QUS), which is non-invasive, inexpensive and portable.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Breast Cancer
Intervention  ICMJE Other: Imaging
Patient in the control arm will receive standard neoadjuvant chemotherapy and clinical monitoring as per standard of care. Patients will be imaged but no modifications to treatment will occur in this trial arm depending on response by quantitative ultrasound. Patients in the experimental arm will receive adaptive neoadjuvant chemotherapy based on quantitative ultrasound monitoring. Non-responders to neoadjuvant chemotherapy based on quantitative ultrasound will be switched to different chemotherapy or other treatments reflecting current clinical practice. The treatment option will be left to the discretion of the treating medical oncologist and the care team.
Study Arms  ICMJE
  • No Intervention: Standard Neoadjuvant Chemotherapy Monitoring
  • Experimental: Adaptive Chemotherapy Monitoring
    Intervention: Other: Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Women ≥ 18 years of age
  2. Diagnosis of breast cancer with a primary tumour >2cm in size
  3. With conditions meeting criteria for chemotherapy administration
  4. Normal hematological blood counts (hemoglobin ≥ 100 g/l, platelet count ≥ 100 x 109, absolute neutrophil count ≥ 2.0 x109 cells per L)
  5. Creatinine ≤175 µmol/L
  6. Liver enzymes (AST and ALT) ≤ 1.5 times upper limit of normal
  7. Cardiac function (left ventricular ejection fraction) ≥55%
  8. Eligible for neoadjuvant chemotherapy.

Exclusion Criteria:

  1. Inflammatory breast cancer
  2. Contraindications to neoadjuvant treatment including pregnancy or lactation
  3. Past medical history of connective tissue disease
  4. Past history of dermatologic disease involving the breast
  5. Eastern Cooperative Group Status (ECOG) ≥3
  6. No peripheral neuropathy of a severity of grade ≥2
  7. Evidence of distant metastatic disease
  8. Known sensitivity to components present in ultrasound gel.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Women ≥ 18 years of age with breast cancer eligible for neoadjuvant chemotherapy
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gregory J Czarnota, PhD, MD (416) 480-6128 gregory.czarnota@sunnybrook.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04050228
Other Study ID Numbers  ICMJE 308-2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sunnybrook Health Sciences Centre
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP