Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-01-01

Brief Summary

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

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Detailed Description

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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).

Conditions

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Invasive Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes