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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Jan 2007 to Dec 17, 2008 Eligibility criteria shortened, about 107 words · Study title shortened, about 5 wordsv11 Show all 3 changesShow less
    • Eligibility criteria shortened, about 107 words
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Jun 2022 to Jun 2027 Completion date: Jun 2024 to Jun 2029v10 Show all 2 changesShow less
    • Completion date: Jun 2024 to Jun 2029
  3. Enrollment target: 100 to 600v9
  4. Primary completion date: Jan 2019 to Jun 2022 Completion date: Jan 2019 to Jun 2024v8 Show all 2 changesShow less
    • Completion date: Jan 2019 to Jun 2024
  5. Re-verified, no change to tracked fieldsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary and study completion dates: Jan 2017 to Jan 2019v6
  2. Primary and study completion dates: Sep 2013 to Jan 2017v5
  3. Primary and study completion dates: Sep 2012 to Sep 2013v4
  4. Enrollment target: 40 to 100v3
  5. Primary and study completion dates: Sep 2012v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00437879
Lead Sponsor Sunnybrook Health Sciences Centre
Conditions Breast Cancer Invasive
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov