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Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contrast Enhanced Digital Mammography
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Neoplasms

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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?

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (CEM)

Arm Description

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

Outcomes

Primary Outcome Measures

Sensitivity of contrast enhanced mammography (CEM) to classify a lesion as benign, probably benign, or suspicious
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.
Sensitivity of MM to classify a lesion as benign, probably benign, or suspicious
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.
Sensitivity of US to classify a lesion as benign, probably benign, or suspicious
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.
Specificity of CEM to classify a lesion as benign, probably benign, or suspicious
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.
Specificity of MM to classify a lesion as benign, probably benign, or suspicious
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.
Specificity of US to classify a lesion as benign, probably benign, or suspicious
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.
False negative rate of CEM
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.
False negative rate of MM
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.
False negative rate of US
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.
False positive rate of CEM
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.
False positive rate of MM
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.
False positive rate of US
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

Positive predictive value of CEM
The positive predictive value of CEM will be calculated and compared to MM+US.
Positive predictive value of MM
The positive predictive value of CEM will be calculated and compared to MM+US.
Positive predictive value of US
The positive predictive value of CEM will be calculated and compared to MM+US.
Negative predictive value of CEM
The negative predictive value of CEM will be calculated and compared to MM+US.
Negative predictive value of MM
The negative predictive value of CEM will be calculated and compared to MM+US.
Negative predictive value of US
The negative predictive value of CEM will be calculated and compared to MM+US.

Full Information

First Posted
April 24, 2019
Last Updated
February 2, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT03929783
Brief Title
Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings
Official Title
Improving PPV3 Using Contrast Enhanced Mammography (CEM) in Diagnostic Assessment by Reducing Benign Tissue Diagnosis (FP3) - A Single-Arm Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
January 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (CEM)
Arm Type
Experimental
Arm Description
Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day.
Intervention Type
Procedure
Intervention Name(s)
Contrast Enhanced Digital Mammography
Other Intervention Name(s)
CEDM, Contrast Enhanced Spectral Mammography
Intervention Description
Undergo CEM
Primary Outcome Measure Information:
Title
Sensitivity of contrast enhanced mammography (CEM) to classify a lesion as benign, probably benign, or suspicious
Description
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.
Time Frame
Up to 1 year
Title
Sensitivity of MM to classify a lesion as benign, probably benign, or suspicious
Description
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.
Time Frame
Up to 1 year
Title
Sensitivity of US to classify a lesion as benign, probably benign, or suspicious
Description
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.
Time Frame
Up to 1 year
Title
Specificity of CEM to classify a lesion as benign, probably benign, or suspicious
Description
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.
Time Frame
Up to 1 year
Title
Specificity of MM to classify a lesion as benign, probably benign, or suspicious
Description
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.
Time Frame
Up to 1 year
Title
Specificity of US to classify a lesion as benign, probably benign, or suspicious
Description
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.
Time Frame
Up to 1 year
Title
False negative rate of CEM
Description
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.
Time Frame
Up to 1 year
Title
False negative rate of MM
Description
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.
Time Frame
Up to 1 year
Title
False negative rate of US
Description
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.
Time Frame
Up to 1 year
Title
False positive rate of CEM
Description
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.
Time Frame
Up to 1 year
Title
False positive rate of MM
Description
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.
Time Frame
Up to 1 year
Title
False positive rate of US
Description
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.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Positive predictive value of CEM
Description
The positive predictive value of CEM will be calculated and compared to MM+US.
Time Frame
Up to 1 year
Title
Positive predictive value of MM
Description
The positive predictive value of CEM will be calculated and compared to MM+US.
Time Frame
Up to 1 year
Title
Positive predictive value of US
Description
The positive predictive value of CEM will be calculated and compared to MM+US.
Time Frame
Up to 1 year
Title
Negative predictive value of CEM
Description
The negative predictive value of CEM will be calculated and compared to MM+US.
Time Frame
Up to 1 year
Title
Negative predictive value of MM
Description
The negative predictive value of CEM will be calculated and compared to MM+US.
Time Frame
Up to 1 year
Title
Negative predictive value of US
Description
The negative predictive value of CEM will be calculated and compared to MM+US.
Time Frame
Up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia Liao
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings

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