NCT04050228Recruiting
Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer
A Phase II Study of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Locally Advanced Breast Cancer (LABC)
Source: ClinicalTrials.gov · Last updated 28 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 22 Jul 2019
- Start date
- 13 Jun 2018
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04050228
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 13 Jun 2018 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inflammatory breast cancer
- Past medical history of connective tissue disease
- Past history of dermatologic disease involving the breast
- Evidence of distant metastatic disease
Other
- Contraindications to neoadjuvant treatment including pregnancy or lactation
- Eastern Cooperative Group Status (ECOG) ≥3
- No peripheral neuropathy of a severity of grade ≥2
- Known sensitivity to components present in ultrasound gel.
Who the study is looking for
- Women ≥ 18 years of age
- Diagnosis of breast cancer with a primary tumour \>2cm in size
- With conditions meeting criteria for chemotherapy administration
- Normal hematological blood counts (hemoglobin ≥ 100 g/l, platelet count ≥ 100 x 109, absolute neutrophil count ≥ 2.0 x109 cells per L)
- Creatinine ≤175 µmol/L
- Liver enzymes (AST and ALT) ≤ 1.5 times upper limit of normal
- Cardiac function (left ventricular ejection fraction) ≥55%
- Eligible for neoadjuvant chemotherapy.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.