Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI

Radiomic Markers for Breast Cancer Metastasis Using Dynamic Contrast Enhanced MRI and Diffusion-Weighted MRI

The primary aim of the study is to identify radiomic features as biomarkers of metastatic progression following primary therapy.

Study Overview

• Status: Completed
• Conditions: Invasive Breast Cancer

Detailed Description

The study aims to evaluate radiomic markers in breast tumors to evaluate metastatic risk based on radiomic features following primary therapy. The investigators aim to analyze images at various time intervals before, during and after primary treatments using two advanced imaging techniques (DCE-MRI & DWI-MRI).

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

This study will enrol women and men with a pathologically-confirmed diagnosis of invasive breast cancer that is stage I-III according to the AJCC v7 criteria.

Description

Inclusion Criteria:

1. Subjects must give appropriate written informed consent prior to participation in the study;
2. Subjects must be able and willing to comply with the safety procedures during the scanning period;
3. Subjects must be men and women age 18+
4. Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-).
5. Stage I-III disease according to the AJCC v7 criteria.
6. Patients with sufficient renal function (creatinine clearance, i.e., >=30 mL/min/1.73 m2).
7. Primary treatments can include neoadjuvant chemotherapy or surgery

Exclusion Criteria:

• 1. Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. Silicone/saline implants) involving either breast, exclusive of the lesion at issue.

  2. Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast 3. Subjects with a current or past medical history of connective tissue disease 4. Subjects who are pregnant or lactating 5. Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator 6. Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety, history of musculoskeletal disease which may predispose them to discomfort during the imaging/scanning period.

  7. Allergies to any contrast agent administered to this study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic complete response (pCR)	Evaluating the degree of absence of residual cancer cells	Up to 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to distant metastasis	Evaluating onset of distant metastasis	Up to 60 months
Time to death	Evaluating time to cancer-related death	Up to 60 months
Time to distant breast cancer recurrence (months)	Evaluating the time until a recurrence event has occurred in the breast.	Up to 60 months

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 214-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No