Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI

Invasive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709186
• Other study ID #: 214-2018
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: October 2019
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Invasive Breast Cancer

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic complete response (pCR)	Evaluating the degree of absence of residual cancer cells	Up to 60 months
Secondary	Time to distant breast cancer recurrence (months)	Evaluating the time until a recurrence event has occurred in the breast.	Up to 60 months
Secondary	Time to distant metastasis	Evaluating onset of distant metastasis	Up to 60 months
Secondary	Time to death	Evaluating time to cancer-related death	Up to 60 months