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Abbreviated Breast MRI After BCT

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ClinicalTrials.gov Identifier: NCT03664778
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
500 patients will be prospectively recruited to undergo a fast breast MRI examination. The women will be recruited for the study will meet the following criteria: 1. status post primary breast cancer treated with breast conservation therapy 3 years prior to recruitment 2. negative DBT examination six months prior to recruitment 3. all breast densities 4. clinically asymptomatic - no palpable masses, focalthickening, or clinically significant discharge We will identify these patients EPIC database utilizing the date of their last mammogram. The patients will be sent a letter explaining the study and the opportunity to enroll in the study. Interested patients may contact our research coordinators by the phone number provided in the letter. The study recruitment information will also be shared with referring physicians. Physicians may also directly refer patients to the study.

Condition or disease
Breast Neoplasms Carcinoma, Intraductal, Noninfiltrating

Detailed Description:
Women treated for primary breast cancer who undergo breast conservation therapy face an increased risk of developing a second breast cancer in the ipsilateral and the contralateral breast. Although mammographic screening is recommended annually, the sensitivity of mammography is limited in these patients due to the post treatment changes from previous surgery and radiation. We propose supplemental screening with an abbreviated form of breast MRI ("fast MRI") examination in addition to mammographic screening, in order to study whether we can detect subclinical disease that may not be detected on mammography or on physical examination. Several tumor characteristics correlate with overall survival such as the extent of local recurrence and the size of the local recurrence, with larger extent and increased size of local recurrence correlating with adverse survival. In addition, the shorter time interval to the ipsilateral breast cancer recurrence from completion of treatment, is associated with increased risk of developing distant metastasis and breast cancer mortality. We will assess additional cancer detection with fast MRI after negative mammography in the ipsilateral as well as the contralateral breast. The goal of the supplemental screening with fast breast MRI would be to detectsubclinical disease not detected on mammography and thus improve patient outcomes.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Cancer Detection Rate of Abbreviated (Fast) Breast MRI (AB-MR) After Negative Digital Breast Tomosynthesis in Women Status Post Conservation Therapy (BCT)
Actual Study Start Date : September 7, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. Invasive breast cancer detection [ Time Frame: 4 years ]
    To detect subclinical disease not detected on mammography


Secondary Outcome Measures :
  1. DCIS and invasive cancer detection rate [ Time Frame: 4 years ]
    To detect DCIS/Cancer not detected on mammography

  2. Tumor size [ Time Frame: 4 years ]
    Tumor size

  3. Axillary nodal status [ Time Frame: 4 years ]
    Axillary nodal status

  4. Time to recurrence [ Time Frame: 4 years ]
    To determine the time of recurrence

  5. Ipsilateral and contralateral breast cancer detection [ Time Frame: 4 years ]
    Ipsilateral and contralateral breast cancer detection



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Ages Eligible for Study:   18 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who have had primary breast cancer treated with breast conservation therapy and who fit the inclusion criteria listed below.
Criteria

Inclusion Criteria:

  1. Status post primary breast cancer (both invasive and DCIS) treated with breast conservation therapy at least three years prior to recruitment
  2. Negative DBT examination within six months prior to recruitment
  3. All breast densities
  4. Clinically asymptomatic - no palpable masses or focal thickening, etc.

Exclusion Criteria:

  1. Patients who are pregnant or lactating.
  2. Patients who have not had a mammogram (digital breast tomosynthesis) in the past 6 months.
  3. Patients who are unwilling or unable to provide written informed consent.
  4. Patients symptomatic for breast disease (e.g. experiencing discharge, lumps, etc.).
  5. Recent breast surgery in the past two years including breast enhancements (e.g. implants or injections) benign surgical biopsies.
  6. Patients who are unable to receive an MRI with Gadolinium contrast.
  7. Patients who have not had an MRI of the breast within the past year.

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): NCT03664778


Contacts
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Contact: Alexa Edenburg, B.S. 2157467050 alexa.edenburg@uphs.upenn.edu

Locations
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United States, Pennsylvania
UPenn Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alexa Edenburg, B.S.    215-746-7050    alexa.edenburg@uphs.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Susan Weinstein, MD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03664778     History of Changes
Other Study ID Numbers: 829400
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Breast Carcinoma In Situ
Carcinoma in Situ
Neoplasms, Ductal, Lobular, and Medullary