Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quantitative ultrasound to guide adaptive chemotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard Neoadjuvant Chemotherapy Monitoring
- description
- 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.
- type
- EXPERIMENTAL
- label
- Adaptive Chemotherapy Monitoring
- description
- 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.
- interventionNames
- Device: Quantitative ultrasound to guide adaptive chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDMoore-Palhares D, Alberico D, Chan AW, DiCenzo D, Sannachi L, Dasgupta A, Yip J, Pena MLA, Gandhi S, Pezo R, Eisen A, Jerzak KJ, Gonzalez CAC, Warner E, Wright FC, Look-Hong N, Roberts A, Sadeghi-Naini A, Curpen B, Skarpathiotakis M, Betel C, Kolios MC, Trudeau M, Czarnota GJ. Quantitative ultrasound imaging for predicting response and guiding personalized neoadjuvant chemotherapy in breast cancer: randomized phase 2 clinical trial results. NPJ Precis Oncol. 2025 Dec 4;9(1):390. doi: 10.1038/s41698-025-01134-x. PMID 41345775
- DERIVEDDasgupta A, DiCenzo D, Sannachi L, Gandhi S, Pezo RC, Eisen A, Warner E, Wright FC, Look-Hong N, Sadeghi-Naini A, Curpen B, Kolios MC, Trudeau M, Czarnota GJ. Quantitative ultrasound radiomics guided adaptive neoadjuvant chemotherapy in breast cancer: early results from a randomized feasibility study. Front Oncol. 2024 Apr 19;14:1273437. doi: 10.3389/fonc.2024.1273437. eCollection 2024. PMID 38706611