Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04764292
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
PA Breast Cancer Coalition
Information provided by (Responsible Party):
Wendie Berg, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Contrast-enhanced mammography Drug: Iodinated Contrast Media (ICM) Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Screening Contrast-Enhanced Mammography as an Alternative to MRI
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arm Intervention/treatment
Experimental: Contrast-enhanced mammography
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.
Device: Contrast-enhanced mammography
supplemental breast cancer screening with contrast-enhanced mammography

Drug: Iodinated Contrast Media (ICM)
supplemental breast cancer screening with contrast-enhanced mammography




Primary Outcome Measures :
  1. Cancer Detection Rate [ Time Frame: 1.5 years ]
    To show significantly improved cancer detection with CEM compared to standard mammography/tomosynthesis


Secondary Outcome Measures :
  1. False Positive Recall Rates [ Time Frame: 1.5 years ]
    To show acceptably low false positive recall rates from CEM.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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).
  2. Women with lobular carcinoma in situ (1% of women biopsied each year; about 0.06% of our screening population) beginning the year after diagnosis.
  3. 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).
  4. 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:

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

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): NCT04764292


Contacts
Layout table for location contacts
Contact: Bonnie Deyo, BS 412-426-5606 deyob@upmc.edu

Locations
Layout table for location information
United States, Pennsylvania
UPMC Magee at the Lemieux Sports Complex Recruiting
Cranberry Township, Pennsylvania, United States, 16066
Magee-Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Bonnie Deyo, BS    412-426-5606    deyob@upmc.edu   
Contact: Wendie Berg, MD, PhD       bergwa@upmc.edu   
Sponsors and Collaborators
Wendie Berg
PA Breast Cancer Coalition
Investigators
Layout table for investigator information
Principal Investigator: Wendie Berg, MD, PhD University of Pittsburgh
Layout table for additonal information
Responsible Party: Wendie Berg, Professor, Department of Radiology, Breast Imaging Division, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04764292    
Other Study ID Numbers: STUDY20110029
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: after publication
Access Criteria: secondary investigators for image analysis. Sharing via Box

Layout table for additional information
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
Keywords provided by Wendie Berg, University of Pittsburgh:
breast cancer supplemental screening
breast density
contrast-enhanced mammography
screening mammography
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases