Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03709186
Recruitment Status :
Active, not recruiting
First Posted : October 17, 2018
Last Update Posted : October 30, 2019
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Dr. William Tran, Sunnybrook Health Sciences Centre
The primary aim of the study is to identify radiomic features as biomarkers of metastatic progression following primary therapy.
Condition or disease
Invasive Breast Cancer
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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Subjects must give appropriate written informed consent prior to participation in the study;
Subjects must be able and willing to comply with the safety procedures during the scanning period;
Subjects must be men and women age 18+
Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-).
Stage I-III disease according to the AJCC v7 criteria.
Patients with sufficient renal function (creatinine clearance, i.e., >=30 mL/min/1.73 m2).
Primary treatments can include neoadjuvant chemotherapy or surgery
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.