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OpenTrials
Completed

NCT Number: NCT03709186

Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

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

Treatment and study plan

Primary outcomes

  1. Pathologic complete response (pCR)

    Time frame: Up to 60 months

    Evaluating the degree of absence of residual cancer cells

Secondary outcomes

  1. Time to distant breast cancer recurrence (months)

    Time frame: Up to 60 months

    Evaluating the time until a recurrence event has occurred in the breast.

  2. Time to distant metastasis

    Time frame: Up to 60 months

    Evaluating onset of distant metastasis

  3. Time to death

    Time frame: Up to 60 months

    Evaluating time to cancer-related death

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 17, 2018
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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