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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings

Clinicaltrials.gov identifier NCT03929783

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted February 23, 2021

Study Description

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:Breast Neoplasms
  • Intervention/Treatment: Procedure: Contrast Enhanced Digital Mammography
  • Phase: N/A
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 or up to 3 days later.

Study Design
  • Study Type: Interventional
  • 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
  • Actual Study Start Date: June 2020
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
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
Outcome Measures
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 30 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 known allergy to iodinated contrast material. - If patient answers YES to any of the below questions they need glomerular filtration rate (gFR) prior to contrast administration regardless of their age: - Have you ever been told you have renal problems? - Have you ever been told you have protein in your urine? - Do you have high blood pressure? - Do you have diabetes? - Do you have gout? - Have you ever had kidney surgery?

Contacts and Locations
Contacts

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

Locations

United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator: Lydia Liao Sidney Kimmel Cancer Center at Thomas Jefferson University

More Information
  • 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: February 23, 2021
  • Last Verified: February 2021
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Breast Neoplasms