Actively Recruiting

FEMALE
NCT00437879

Ultrasound Imaging, Spectroscopy and Ultrasound Imaging of Vascular Blood Flow as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment.

Led by Sunnybrook Health Sciences Centre · Updated on 2023-12-12

600

Participants Needed

1

Research Sites

1067 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

We 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. The objectives of this study are to evaluate the use of ultrasound imaging and spectroscopy as a predictive marker of advanced tumour response to combined chemotherapy and radiotherapy. Since neoadjuvant treatments may also act on tumour vasculature to "normalize" it we will also evaluate blood-vessel imaging by standard Doppler-imaging and with standard higher-resolution imaging using clinically approved microbubble contrast agents. The main goal, as described above, is to select the best ultrasound spectroscopy parameter to use as an early predictor of pathological complete response.

CONDITIONS

Official Title

Ultrasound Imaging, Spectroscopy and Ultrasound Imaging of Vascular Blood Flow as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment.

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed breast carcinoma, stage I-IV, untreated with first-line therapy and planned for neoadjuvant chemotherapy or combined chemo-radiotherapy
  • Measurable disease by ultrasound or MRI within 28 days before treatment
  • Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of at least 6 months
  • Adequate bone marrow, liver, and kidney function based on recent lab tests
  • Ability and willingness to provide informed consent before study procedures
Not Eligible

You will not qualify if you...

  • Chemotherapy, radiotherapy, or major surgery within 4 weeks before study registration or incomplete recovery from related side effects
  • Currently receiving any other investigational drugs
  • Known brain metastases
  • History of allergic reactions to similar chemical or biological compounds

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

G

Gregory J. Czarnota

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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