Pilot Investigation of Ultrasound Imaging and Spectroscopy as Early Indicators of Locally- Advanced Breast Cancer Response to Neoadjuvant Treatment

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment

• Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1

• Life expectancy of at least 6 months

• 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

Locations
United States
Texas
MD Anderson
COMPLETED
Houston
Other Locations
Canada
Princess Margaret Cancer Centre
COMPLETED
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Gregory J Czarnota, PhD, MD
gregory.czarnota@sunnybrook.ca
(416) 480-6128
Time Frame
Start Date: 2014-08
Estimated Completion Date: 2029-10
Participants
Target number of participants: 150
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov