CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 240 target
Drug / intervention
Quantitative ultrasound to guide adaptive chemotherapydevice
Likely dose
Not stated in record
Key inclusion· 4
  • Women aged 18 years or older
  • Breast cancer with primary tumor >2cm
  • Meets criteria for chemotherapy administration
  • Eligible for neoadjuvant chemotherapy
Key exclusion· 6
  • Inflammatory breast cancer
  • Pregnancy or lactation
  • History of connective tissue disease
  • History of dermatologic disease involving the breast

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04050228
NCT04050228N/ARecruitingUpdate OverdueUpdated 30mo ago · Completion was 13mo ago
Enrollment Stalled
Long Recruiting
Update Overdue

A Phase II Study of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Locally Advanced Breast Cancer (LABC)

Sunnybrook Health Sciences Centre·interventional·Posted Aug 8, 2019·Updated Dec 28, 2023

In Brief

A clinical study evaluating Quantitative ultrasound to guide adaptive chemotherapy for Breast Cancer. Currently recruiting, targeting 240 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada
Collaborators--

Timeline

N/ARecruiting
20192020202120222023202420252026202720282029
First PostedAug 8, 2019
Enrollment StartJun 13, 2018
Primary CompletionJun 1, 2025
Study CompletionJun 1, 2029
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 6.9 years ago

Interventions

Quantitative ultrasound to guide adaptive chemotherapydevice

Quantitative ultrasound results will be used to measure chemotherapy response and guide an adaptive chemotherapy strategy for patients who are found to be nonresponders to their chemotherapy.