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Screening Contrast-Enhanced Mammography as an Alternative to MRI (SCEMAM)

Primary Purpose

Breast Cancer

Status

Active

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Contrast-enhanced mammography

Iodinated Contrast Media (ICM)

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring breast cancer supplemental screening, breast density, contrast-enhanced mammography, screening mammography

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Asymptomatic women under age 75 who are recommended for annual screening MRI and mammography based on current criteria:
1. Women known to be at high risk for breast cancer because of known or suspected pathogenic mutation, prior chest radiation therapy at least 8 years earlier and before age 30, or estimated lifetime risk of at least 20% based on family history/prior biopsy history (22), between age 30 and 75.
2. Women with extremely dense breasts age 40-75 (about 7% of the screening population (1)) (12).
Women with lobular carcinoma in situ (1% of women biopsied each year; about 0.06% of our screening population) beginning the year after diagnosis.
Women with a personal history of breast cancer diagnosed by age 50 or with dense breasts (21), beginning the year after diagnosis (will be recruited under separate ongoing TOCEM protocol).
Women with heterogeneously dense breasts and any family history of breast cancer (about 36% of the screening population has dense breasts and about 20% have a family history of breast cancer) who do not meet current high-risk criteria, beginning at age 40 or ten years prior to the age of the youngest relative but not before age 30.

Participants are expected to have medical or other reasons that they are not able to have screening breast MRI.

Exclusion Criteria:

Under age 30 or over age 75.
Pregnant or breast feeding.
Breast implants.
Breast surgery within the prior 12 months.
Breast signs or symptoms (lump, nipple discharge, nipple retraction, or being followed for breast abnormality on prior imaging).
Currently undergoing any type of systemic chemotherapy for cancer (excludes oral endocrine therapy such as aromatase inhibitors or tamoxifen).
Reduced kidney function with eGFR < 45 mL/min.

Sites / Locations

UPMC Magee at the Lemieux Sports Complex
UPMC Magee Monroeville Breast Care Center
Magee-Womens Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contrast-enhanced mammography

Arm Description

Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography. Women will also have standard-of-care mammography/tomosynthesis per usual clinical practice.

Outcomes

Primary Outcome Measures

Cancer Detection Rate

To show significantly improved cancer detection with CEM compared to standard mammography/tomosynthesis

Secondary Outcome Measures

False Positive Recall Rates

To show acceptably low false positive recall rates from CEM.

Full Information

NCT ID

NCT04764292

First Posted

February 17, 2021

Last Updated

January 12, 2023

Sponsor

Wendie Berg

Collaborators

PA Breast Cancer Coalition

1. Study Identification

Unique Protocol Identification Number

NCT04764292

Brief Title

Screening Contrast-Enhanced Mammography as an Alternative to MRI

Acronym

SCEMAM

Official Title

Screening Contrast-Enhanced Mammography as an Alternative to MRI

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 15, 2021 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Wendie Berg

Collaborators

PA Breast Cancer Coalition

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.

Data Monitoring Committee

5. Study Description

Brief Summary

There are women for whom a screening breast MRI is clinically recommended, but not feasible either due to patient factors (body habitus, pacemaker or other implant, claustrophobia) or access (cost, other constraints). Contrast-enhanced mammography (CEM) is a potential alternative to MRI for screening that uses updated standard mammography equipment to obtain low- and high-energy images after intravenous injection of iodinated contrast (as used in CT scanning). The investigators seek to validate screening CEM as an alternative to screening MRI.

Detailed Description

This is a prospective study designed to evaluate the role of contrast enhanced mammography (CEM) in screening for breast cancer. The overarching goal of the research program is to improve cancer detection on screening, particularly in women with dense breasts. MRI depicts more cancers than other screening methods, including ultrasound. MRI is proven to both improve cancer detection and reduce clinically detected cancers ("interval cancers") after a negative screening mammogram in women with dense breasts. PA Senate Bill 595, signed into law June 30, 2020, requires insurance carriers to provide coverage for supplemental screening with MRI or ultrasound for a variety of indications. Relative to the number of women who may benefit from screening MRI, there is a shortage of equipment/capacity. Further, nearly half of women cannot have an MRI for medical or other reasons, such as claustrophobia, implanted devices, body habitus, or cost (deductible and copay apply even with the new legislation). Contrast-enhanced mammography (CEM) appears to have similar performance to MRI but has not been widely validated, particularly for screening. In order to lay the foundation for improved screening of women with dense breasts, the investigators seek to offer screening CEM as an alternative to MRI for women who meet guidelines for screening MRI but are unable to have MRI.

6. Conditions and Keywords

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

Breast Cancer

Keywords

breast cancer supplemental screening, breast density, contrast-enhanced mammography, screening mammography

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Contrast-enhanced mammography

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Contrast-enhanced mammography

Intervention Description

supplemental breast cancer screening with contrast-enhanced mammography

Intervention Type

Drug

Intervention Name(s)

Iodinated Contrast Media (ICM)

Intervention Description

supplemental breast cancer screening with contrast-enhanced mammography

Primary Outcome Measure Information:

Title

Cancer Detection Rate

Description

To show significantly improved cancer detection with CEM compared to standard mammography/tomosynthesis

Time Frame

1.5 years

Secondary Outcome Measure Information:

Title

False Positive Recall Rates

Description

To show acceptably low false positive recall rates from CEM.

Time Frame

1.5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Asymptomatic women under age 75 who are recommended for annual screening MRI and mammography based on current criteria: Women known to be at high risk for breast cancer because of known or suspected pathogenic mutation, prior chest radiation therapy at least 8 years earlier and before age 30, or estimated lifetime risk of at least 20% based on family history/prior biopsy history (22), between age 30 and 75. Women with extremely dense breasts age 40-75 (about 7% of the screening population (1)) (12). Women with lobular carcinoma in situ (1% of women biopsied each year; about 0.06% of our screening population) beginning the year after diagnosis. Women with a personal history of breast cancer diagnosed by age 50 or with dense breasts (21), beginning the year after diagnosis (will be recruited under separate ongoing TOCEM protocol). Women with heterogeneously dense breasts and any family history of breast cancer (about 36% of the screening population has dense breasts and about 20% have a family history of breast cancer) who do not meet current high-risk criteria, beginning at age 40 or ten years prior to the age of the youngest relative but not before age 30. Participants are expected to have medical or other reasons that they are not able to have screening breast MRI. Exclusion Criteria: Under age 30 or over age 75. Pregnant or breast feeding. Breast implants. Breast surgery within the prior 12 months. Breast signs or symptoms (lump, nipple discharge, nipple retraction, or being followed for breast abnormality on prior imaging). Currently undergoing any type of systemic chemotherapy for cancer (excludes oral endocrine therapy such as aromatase inhibitors or tamoxifen). Reduced kidney function with eGFR < 45 mL/min.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wendie Berg, MD, PhD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC Magee at the Lemieux Sports Complex

City

Cranberry Township

State/Province

Pennsylvania

ZIP/Postal Code

16066

Country

United States

Facility Name

UPMC Magee Monroeville Breast Care Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15146

Country

United States

Facility Name

Magee-Womens Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

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

IPD Sharing Access Criteria

secondary investigators for image analysis. Sharing via Box

Learn more about this trial

Screening Contrast-Enhanced Mammography as an Alternative to MRI

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