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CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
contrast enhanced mammography
Iodinated Contrast Media (ICM)
Sponsored by
Margarita Louise Zuley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject is female of any race and ethnicity
  • Subject is ≥30 years old
  • Subject is diagnosed with a suspicious breast abnormality and is scheduled for an imaging directed breast biopsy.

Exclusion Criteria:

  • Subject is unable or unwilling to undergo informed consent
  • Subject has a breast implant in the breast of interest
  • Subject is pregnant
  • Subject is breast-feeding
  • Subject is actively being treated for cancer of any type with chemotherapy
  • Subject has reduced kidney function with eGFR < 45.
  • Subject has had a prior reaction to iodinated contrast; thus a known allergy to iodinated contrast

Sites / Locations

  • UPMC Magee-Womens HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

contrast enhanced mammography

Arm Description

Women who have been recently diagnosed with a suspicious abnormality for which they have scheduled a breast biopsy and meet inclusion criteria will be invited to have a contrast enhanced mammography before their scheduled biopsy procedure.

Outcomes

Primary Outcome Measures

Negative Predictive Value (NPV)
The investigators will estimate and compare the changes in NPV of pre- and post CEM-based recommendations (where NPV is the proportion of pathology verified benign lesions out of post-CEM-downgraded to BIRADS 3 or lower).

Secondary Outcome Measures

Positive Predictive Value of biopsies performed (PPV3)
The investigators will estimate and compare the corresponding improvements in PPV3 in soft-tissue and calcification index-lesion cohorts.

Full Information

First Posted
January 4, 2022
Last Updated
July 6, 2023
Sponsor
Margarita Louise Zuley
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05206331
Brief Title
CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
Official Title
Contrast Enhanced Mammography (CEM) to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Margarita Louise Zuley
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
One of the primary criticisms of mammography is that it leads to unneeded stress and anxiety from identification and biopsy of non-cancerous findings. Contrast-enhanced mammography (CEM) has the potential to significantly reduce biopsy rates for commonly seen benign breast lesions while preserving very high cancer detection. The investigators propose a prospective clinical study of patients with diagnostic mammograms rated as BIRADS 4A or 4B and scheduled for a biopsy, in which, prior to undergoing their scheduled biopsy, a CEM procedure is performed. The investigators will test the primary hypothesis that for soft tissue lesions (i.e. masses, asymmetries, architectural distortions) initially rated BI-RADS 4A/4B adding CEM will reduce, by at least 20%, the number of biopsy recommendations for actually benign cases and, at the same time, provide a negative predictive value (NPV) higher than 95%.
Detailed Description
The investigators believe that an operationally simple, cost effective, contrast enhanced mammogram (CEM), performed during the patient's diagnostic evaluation, would be the best approach to improve the accuracy of radiologists' decisions for need to biopsy lesions classified with mammography, tomosynthesis (DBT) or ultrasound as 4A or 4B. CEM uses iodine contrast with dual low and high KeV mammogram images to create a contrast enhancement map of the breast that directly overlays the mammogram, thus providing anatomic and kinetic information, similar to MRI. The investigators found in a preliminary clinical trial that radiologists had higher true-positive rates and lower false-positive rates for biopsy recommendation with CEM than when using DBT and ultrasound. To validate those initial findings, the investigators propose to prospectively and sequentially perform CEM on 1855 consenting women with BIRADS 4A or 4B lesions detected on mammography, DBT or ultrasound. Prospectively radiologists will provide BIRADS ratings for every lesion using DBT alone, then with ultrasound and finally with CEM. With pathology known and based on the study design to minimize case by radiologist potential biases, the investigators plan to estimate the NPV level of CEM-based recommendations (overall and within the cases with conventionally confirmed biopsy recommendation) and demonstrate that it is sufficiently high, while leading to substantial reduction in biopsy recommendations for actually benign lesions. The investigators primary expectation is that the number of recommendations to biopsy benign lesions will decrease significantly (~20%), while maintaining high NPV (>95%) among the initial recommendations.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
eligible participants will have contrast enhanced mammography before their scheduled biopsy
Masking
None (Open Label)
Allocation
N/A
Enrollment
1855 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
contrast enhanced mammography
Arm Type
Experimental
Arm Description
Women who have been recently diagnosed with a suspicious abnormality for which they have scheduled a breast biopsy and meet inclusion criteria will be invited to have a contrast enhanced mammography before their scheduled biopsy procedure.
Intervention Type
Device
Intervention Name(s)
contrast enhanced mammography
Intervention Description
Dual-energy contrast images; low-energy CEM images will be obtained with a kilovoltage below 35 kVp while the high-energy images will be obtained with 45-49 kVp.The average glandular dose of the CEM procedure is approximately 2.44 mGy per view
Intervention Type
Drug
Intervention Name(s)
Iodinated Contrast Media (ICM)
Intervention Description
standard FDA-approved low osmolarity Iodine contrast agent with 350-370 mg/ml
Primary Outcome Measure Information:
Title
Negative Predictive Value (NPV)
Description
The investigators will estimate and compare the changes in NPV of pre- and post CEM-based recommendations (where NPV is the proportion of pathology verified benign lesions out of post-CEM-downgraded to BIRADS 3 or lower).
Time Frame
year 5
Secondary Outcome Measure Information:
Title
Positive Predictive Value of biopsies performed (PPV3)
Description
The investigators will estimate and compare the corresponding improvements in PPV3 in soft-tissue and calcification index-lesion cohorts.
Time Frame
year 5
Other Pre-specified Outcome Measures:
Title
Frequencies
Description
The investigators will estimate the magnitude of the reduction in biopsies of benign soft-tissue index lesions (which approximates the increase in patient-level
Time Frame
year 5
Title
Positive predictive value of biopsy recommendations (PPV2)
Description
The investigators will evaluate PPV of biopsy recommendations pre- and post-CEM by lesions' imaging appearance (mass, distortion, etc.).
Time Frame
year 5

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject is female of any race and ethnicity Subject is ≥30 years old Subject is diagnosed with a suspicious breast abnormality and is scheduled for an imaging directed breast biopsy. Exclusion Criteria: Subject is unable or unwilling to undergo informed consent Subject has a breast implant in the breast of interest Subject is pregnant Subject is breast-feeding Subject is actively being treated for cancer of any type with chemotherapy Subject has reduced kidney function with eGFR < 45. Subject has had a prior reaction to iodinated contrast; thus a known allergy to iodinated contrast
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Burdin, BS
Phone
412-647-7385
Email
burdins@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita L Zuley, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Burdin, BS
Phone
412-647-7385
Email
burdins@upmc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Images may be shared with secondary investigators, including commercial companies after removal of all identifiers. All patient identification (name, patient number, birth date) will be removed from the DICOM headers of the images.
IPD Sharing Time Frame
after publication for indefinitely
IPD Sharing Access Criteria
secondary investigators for image analysis. Sharing via Box

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CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study

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