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

NCT00437879 | Recruiting DMC

• 1 other identifier: 185-2006
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer Invasive

Keywords

Breast Cancer; Ultrasound; Neoadjuvant Treatment

Outcome Measures

Primary Outcomes (1)

• The primary Outcome will be correlate changes in ultrasound backscatter parameters obtained throughout the course of treatment with pathological complete, partial, or complete and partial response.

  Ultrasound spectroscopy parameters to be examined include mid-band fit parameters, spectral slope and histogram distribution fit parameters related to scatterer size and concentration. From these various receiver-operator curves, the best ultrasound parameter predictive response will be selected and will aid to define the clinical specificity and sensitivity of The technique.

  2 and 5-year long-term clinical outcome

Secondary Outcomes (2)

• The secondary Outcome of this study will include examining the change in tumor size.

  2 and 5-year long-term clinical outcome

• Other secondary Outcome will include measuring changes in the blood vessels distribution in the tumor.

  2 and 5-year long-term clinical outcome

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who are receiving neoadjuvant chemotherapy or neoadjuvant chemo-radiotherapy for breast cancer.

You may qualify if:

• The following criteria are necessary for study participation:
• Histologically or cytologically confirmed breast carcinoma, stage I-IV, 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.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory. Requirements to be conducted within 7 days prior to dosing:
• (i) hemoglobin \>90 mg/dL (ii) leukocytes \>3,000/mL (iii) absolute neutrophil count \>1,500/mL (iv) platelets \>100,000/mL (v) total bilirubin within normal institutional limits (vi) AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal (vii) creatinine within normal institutional limits or creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal
• 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.

You may not qualify if:

• The following conditions will exclude women from participation:
• Chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration.
• Receiving any other investigational agents.
• Known brain metastases.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gregory J. Czarnota, Ph.D. M.D.

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory J. Czarnota

CONTACT

416-480-5329; Gregory.Czarnota@sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 21, 2007
• Study Start: December 17, 2008
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

CA (1)