Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI

Completed

• Conditions: Invasive Breast Cancer

• Registration Number: NCT03709186
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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

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 Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Status Verified: 2019-10
• Primary Completion: 2020-09-01
• Study Completion: 2021-01-01
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic complete response (pCR)	Up to 60 months	Evaluating the degree of absence of residual cancer cells

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada