Three-Dimensional Ultrasound and Spectroscopy as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment

NCT06193122 | Not Yet Recruiting

• 1 other identifier: 5552
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to test the hypothesis that ultrasound imaging and spectroscopy may be used as a predictive marker of advanced tumour response to neoadjuvant treatment consisting of chemotherapy or concurrent chemotherapy-radiotherapy. The main goal is to select the best ultrasound spectroscopy parameter and vascular-distribution index to use as an early predictor of pathological complete or partial response as a primary endpoint and tumour size decrease as a secondary endpoint.

Conditions

Breast Cancer

Keywords

Neoadjuvant Chemotherapy; Three-Dimensional Ultrasound; Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Ultrasound imaging and spectroscopy as a predictive marker of early predictor of complete pathological response.

  The primary endpoint of this study will be to correlate changes in ultrasound backscatter parameters obtained throughout the course of treatment with complete or partial pathological response.

  Up to 5 years

Secondary Outcomes (2)

• To Examine the change in tumour size over the course of treatment and correlating it to changes in ultrasound backscatter parameters.

  Up to 5 years

• To Examine the change in tumour Volumen over the course of treatment and correlating it to changes in ultrasound backscatter parameters.

  Up to 5 years

Study Arms (1)

Standard neoadjuvant treatments

Patients will be assessed using ultrasound imaging 3D and spectroscopy at the following intervals: once immediately prior to commencing neoadjuvant treatment. Once treatment begins, patients will be imaged at weeks 2, 4, 8, 12 and then prior to their surgery.

Device: Ultrasound imaging 3D and Spectroscopy

Interventions

Ultrasound imaging 3D and Spectroscopy DEVICE

Ultrasound imaging and spectroscopy will consist of collecting three dimensional data. Regions of interest in each of the tumour images and in the adjacent normal tissue will be selected for analysis.

Standard neoadjuvant treatments

Eligibility Criteria

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

Study Population

Men and women and members of all races and ethnic groups who will receive standard Neoadjuvant treatment for Breast Cancer.

You may qualify if:

• 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.
• Disease must be measurable 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:

• 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.
• Contraindications to radiotherapy such as but not limited to:
• (i) previous radiotherapy to an involved area (ii) active collagen vascular disease (iii) genetic diseases associated with hyper-radiosensitivity.
• Any clinically serious infections requiring systemic anti-bacterial, antifungal or antiviral therapy.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia.
• Psychiatric illness/social situations that would limit compliance with study requirements.
• History of active ongoing seizure disorder.
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
• Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Spectrum Analysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Gregory J Czarnota, PhD, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory J Czarnota, PhD, MD

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: Radiation Oncologist and Clinical Scientist

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 5, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2029
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)