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Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI

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ClinicalTrials.gov Identifier: NCT03709186
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. William Tran, Sunnybrook Health Sciences Centre

Brief Summary:
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

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).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Radiomic Markers for Breast Cancer Metastasis Using Dynamic Contrast Enhanced MRI and Diffusion-Weighted MRI
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. Pathologic complete response (pCR) [ Time Frame: Up to 60 months ]
    Evaluating the degree of absence of residual cancer cells


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709186


Contacts
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Contact: William T. Tran, MRT(T), PhD 416-480-6100 ext 3746 william.tran@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Gregory Czarnota, MD, PhD    416-480-6128    gregory.czarnota@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: William T. Tran, MRT(T), PhD Radiation Therapist Clinician Scientist
Principal Investigator: Colleen Bailey, PhD Sunnybrook Research Institute
Principal Investigator: Angus Lau, PhD Sunnybrook Research Institute
Principal Investigator: Kasia Jerzak, MD, MSc Sunnybrook Health Sciences Centre

Additional Information:

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Responsible Party: Dr. William Tran, Radiation Therapist Clinician Scientist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03709186     History of Changes
Other Study ID Numbers: 214-2018
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases