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Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings

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ClinicalTrials.gov Identifier: NCT03929783
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
This pilot trial studies how well contrast enhanced mammography works in diagnosing patients with suspicious breast findings. Diagnostic procedures, such as contrast enhanced mammography, may help to reclassify findings seen on diagnostic mammography and ultrasound as benign or likely benign with what would otherwise require biopsy for confirmation.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Procedure: Contrast Enhanced Digital Mammography Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To obtain preliminary data to support the hypothesis that contrast enhanced mammography (CEM) can reduce benign tissue diagnosis (FP3) and therefore improve positive predictive value 3 (PPV3).

SECONDARY OBJECTIVES:

I. Identify specific CEM characteristics that accurately classify a finding as benign, high-risk or malignant.

II. Assess the positive and negative predictive values for each digital breast tomosynthesis (DBT), breast ultrasound and CEM.

EXPLORATORY OBJECTIVES:

I. To compare the outcomes/endpoints stratified by age to determine if age affects the ability of CEM to accurately define a lesion as benign, probably benign or suspicious.

OUTLINE:

Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Improving PPV3 Using Contrast Enhanced Mammography (CEM) in Diagnostic Assessment by Reducing Benign Tissue Diagnosis (FP3) - A Single-Arm Prospective Study
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arm Intervention/treatment
Experimental: Diagnostic (CEM)
Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day.
Procedure: Contrast Enhanced Digital Mammography
Undergo CEM
Other Names:
  • CEDM
  • Contrast Enhanced Spectral Mammography




Primary Outcome Measures :
  1. Sensitivity of contrast enhanced mammography (CEM) to classify a lesion as benign, probably benign, or suspicious [ Time Frame: Up to 1 year ]
    The total number of suspicious and benign lesions on each modality (mammogram+ultrasound [MM+US] and CEM) will be calculated and compared to a final tissue diagnosis independently.

  2. Sensitivity of MM to classify a lesion as benign, probably benign, or suspicious [ Time Frame: Up to 1 year ]
    The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.

  3. Sensitivity of US to classify a lesion as benign, probably benign, or suspicious [ Time Frame: Up to 1 year ]
    The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.

  4. Specificity of CEM to classify a lesion as benign, probably benign, or suspicious [ Time Frame: Up to 1 year ]
    The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.

  5. Specificity of MM to classify a lesion as benign, probably benign, or suspicious [ Time Frame: Up to 1 year ]
    The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.

  6. Specificity of US to classify a lesion as benign, probably benign, or suspicious [ Time Frame: Up to 1 year ]
    The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.

  7. False negative rate of CEM [ Time Frame: Up to 1 year ]
    The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.

  8. False negative rate of MM [ Time Frame: Up to 1 year ]
    The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.

  9. False negative rate of US [ Time Frame: Up to 1 year ]
    The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.

  10. False positive rate of CEM [ Time Frame: Up to 1 year ]
    The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.

  11. False positive rate of MM [ Time Frame: Up to 1 year ]
    The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.

  12. False positive rate of US [ Time Frame: Up to 1 year ]
    The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.


Secondary Outcome Measures :
  1. Positive predictive value of CEM [ Time Frame: Up to 1 year ]
    The positive predictive value of CEM will be calculated and compared to MM+US.

  2. Positive predictive value of MM [ Time Frame: Up to 1 year ]
    The positive predictive value of CEM will be calculated and compared to MM+US.

  3. Positive predictive value of US [ Time Frame: Up to 1 year ]
    The positive predictive value of CEM will be calculated and compared to MM+US.

  4. Negative predictive value of CEM [ Time Frame: Up to 1 year ]
    The negative predictive value of CEM will be calculated and compared to MM+US.

  5. Negative predictive value of MM [ Time Frame: Up to 1 year ]
    The negative predictive value of CEM will be calculated and compared to MM+US.

  6. Negative predictive value of US [ Time Frame: Up to 1 year ]
    The negative predictive value of CEM will be calculated and compared to MM+US.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with digital breast tomosynthesis and/or ultrasound assessments of Breast Imaging Reporting and Data System (BI-RADS) 4 and 5 lesions with recommendation of needle biopsy for tissue diagnosis.
  • Abnormal findings include masses, focal, global or developing asymmetries, architecture distortions, or > 1 cm of suspicious calcifications with or without associated ultrasound abnormal findings.
  • Scheduled for imaging guided percutaneous needle biopsy.
  • Provide signed and dated informed consent form.
  • If patient is of childbearing potential, a negative pregnancy test, urine or blood, within 14 days prior to the scan.

Exclusion Criteria:

  • < 1 cm span of calcifications without an ultrasound correlate.
  • Pregnant patients.
  • Patients with a glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2 (based on lab results within 30 days prior to exam) or with chronic kidney disease on hemodialysis.
  • Patients with known allergy to iodinated contrast material.

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): NCT03929783


Contacts
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Contact: Lydai Liao 215-955-5412 lydia.liao@jefferson.edu

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Lydia Liao Sidney Kimmel Cancer Center at Thomas Jefferson University

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03929783     History of Changes
Other Study ID Numbers: 19D.203
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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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