Clinical trial · Observational
Ultrasound Imaging and Spectroscopy as Early Indicators of Locally-Advanced Breast Cancer Response
Pilot Investigation of Ultrasound Imaging and Spectroscopy as Early Indicators of Locally- Advanced Breast Cancer Response to Neoadjuvant Treatment
- 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)
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.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Measuring the rate of treatment response between the treatment groups
- timeFrame
- Up to 5 years
- description
- Correlate changes in ultrasound backscatter parameters obtained throughout the course of treatment with pathological complete or partial response
Secondary outcomes (1)
- measure
- Inter-user variability comparison
- timeFrame
- Up to 5 years
- description
- Comparing second site data analysis outcomes with central co-coordinating site data analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available