Clinical trial NCT03709186: Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI
Official title: Radiomic Markers for Breast Cancer Metastasis Using Dynamic Contrast Enhanced MRI and Diffusion-Weighted MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Breast Cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Pathologic complete response (pCR)
timeFrame: Up to 60 months
Secondary outcomes:
measure: Time to distant breast cancer recurrence (months)
timeFrame: Up to 60 months
measure: Time to distant metastasis
timeFrame: Up to 60 months
measure: Time to death
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Radiation Therapist Clinician Scientist
name: William T. Tran, MRT(T), PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Research Institute
name: Colleen Bailey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Research Institute
name: Angus Lau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Kasia Jerzak, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: