Recruiting

Quantitative Ultrasound

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04050228

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quantitative ultrasound to guide adaptive chemotherapy

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT04050228

Start date

Jun 13, 2018

Status verified date

Dec, 2023

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard Neoadjuvant Chemotherapy Monitoring

Patients who will be randomized to the control arm with Standard Neoadjuvant Chemotherapy Monitoring will receive Phase I chemotherapy consisting of anthracycline-based treatment followed by Phase II chemotherapy consisting of taxane-based treatment.

Patients will be imaged but no modifications to treatment will occur in this trial arm depending on response by quantitative ultrasound.

experimental: Adaptive Chemotherapy Monitoring

Patients who will be randomized to the experimental arm Adaptive Chemotherapy Monitoring and demonstrate Response (+) will continue until standard chemotherapy is completed. For patients who do not demonstrate response after 4 weeks of chemotherapy, an early switch to the second phase of chemotherapy could occur (Phase II/Taxane) At the discretion of the treating medical oncologist.

Patients will undergo Quantitative Ultrasound on the following time points: Pre-treatment, Weeks 1, 4, 8, 12 and Pre-Operatively. These QUS time points correspond to the following chemotherapy times.

Interventions

Quantitative ultrasound to guide adaptive chemotherapy

Quantitative ultrasound results will be used to measure chemotherapy response and guide an adaptive chemotherapy strategy for patients who are found to be nonresponders to their chemotherapy.

Primary outcome measure

  • Measuring the rate of treatment response between the treatment groups [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Gregory J Czarnota, PhD, MD

(416) 480-6128gregory.czarnota@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Gregory J Czarnota, PhD, MD

(416) 480-6128gregory.czarnota@sunnybrook.ca

Principal Investigator:

Maureen E Trudeau, MD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Dec 28, 2023

Last verified

Dec, 2023

Keywords

  • Ultrasound, Chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-12-28.