Trials / Not Yet Recruiting
Not Yet RecruitingNCT06193122
Three-Dimensional Ultrasound and Spectroscopy as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment
Investigation of Three-Dimensional Ultrasound and Spectroscopy as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Sunnybrook Health Sciences Centre · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to test the hypothesis that ultrasound imaging and spectroscopy may be used as a predictive marker of advanced tumour response to neoadjuvant treatment consisting of chemotherapy or concurrent chemotherapy-radiotherapy. The main goal is to select the best ultrasound spectroscopy parameter and vascular-distribution index to use as an early predictor of pathological complete or partial response as a primary endpoint and tumour size decrease as a secondary endpoint.
Detailed description
This project is an early validation study in human subjects that will use three-dimensional ultrasound imaging and spectroscopy to monitor cell death occurring at various time points during a patient's treatment for advanced breast cancer. Standard neoadjuvant treatments for breast cancer consisting of combined chemotherapy and radiotherapy will be used in patients. Reponses will be followed with ultrasound imaging and spectroscopy at regular predetermined time-points. The research is exploratory since upon data analysis it will examine the use of different ultrasound backscatter parameters as potential markers of cell death and correlate these with changes in tumour size and complete pathological response.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ultrasound imaging 3D and Spectroscopy | Ultrasound imaging and spectroscopy will consist of collecting three dimensional data. Regions of interest in each of the tumour images and in the adjacent normal tissue will be selected for analysis. |
Timeline
- Start date
- 2024-04-01
- Primary completion
- 2026-04-01
- Completion
- 2029-04-01
- First posted
- 2024-01-05
- Last updated
- 2024-01-05
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT06193122. Inclusion in this directory is not an endorsement.