Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tomosynthesis vs. Contrast-Enhanced Mammography in Women With Personal History of Breast Cancer in Western Pennsylvania (TOCEM)

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: NCT04085510
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Wendie Berg, University of Pittsburgh

Brief Summary:
This is a prospective clinical trial that will examine if contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false-positives, in women with a personal history of breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Breast Cancer Breast Neoplasms Neoplasms Device: Contrast-enhanced mammogram Not Applicable

Detailed Description:
The investigators expect to show in a prospective clinical trial that, in women with a personal history of breast cancer, contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false positives. The investigators expect a substantial increase in node-negative invasive cancers in particular. Because DBT will be interpreted first by one reader, and CEM will be interpreted first, and independently, by a second reader, there will also be an assessment of performance of tomosynthesis alone or CEM alone in this population.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1650 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Improving Surveillance of Women With Personal History of Breast Cancer Using Contrast-Enhanced Mammography (CEM)
Actual Study Start Date : October 23, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : March 28, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Contrast-enhanced mammogram
All women will receive both 3D mammography and contrast-enhanced mammography for breast cancer screening; the order of interpretation will vary for each of two radiologists
Device: Contrast-enhanced mammogram
Contrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography and/or ultrasound examinations to localize a known or suspected lesion.




Primary Outcome Measures :
  1. Cancer Detection [ Time Frame: 18 months ]
    Number of participants with cancer detected with contrast-enhanced mammography compared to tomosynthesis. Number of patients recalled for additional testing by each imaging test who do not have cancer (false positives).


Secondary Outcome Measures :
  1. Reader Validation [ Time Frame: 24 months ]
    Reader validation will be performed at study conclusion: number of cancers detected with contrast-enhanced mammography or tomosynthesis.



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 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment.

Exclusion Criteria:

  • Women with a history of prior iodinated contrast reaction
  • Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions)
  • Women who have had bilateral mastectomy
  • Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) < 60 mL/min
  • Pregnancy or lactation
  • Contraindication to magnetic resonance imaging (MRI) (if needed for biopsy guidance): Pacemaker, metallic implant near vital structure, history of reaction to gadolinium-based contrast; body habitus (typically weight > 300 lbs) incompatible with scanner; hardware that would cause artifacts in the breasts (e.g. spinal fixation rods)
  • Severe claustrophobia
  • Women actively being treated for cancer of any type with chemotherapy.

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): NCT04085510


Contacts
Layout table for location contacts
Contact: Nicole Lettiere, BA 412-641-8283 lettieren@upmc.edu
Contact: Bonnie Deyo, BS 412-641-8278 deyob@upmc.edu

Locations
Layout table for location information
United States, Pennsylvania
Magee Womancare Passavant Cranberry Recruiting
Cranberry Township, Pennsylvania, United States, 16066
Contact: Nicole Lettiere, BA    412-641-8283    lettieren@upmc.edu   
Contact: Bonnie Deyo, BS    412-641-8278    deyob@upmc.edu   
Principal Investigator: Wendie Berg, MD, PhD         
Magee Womancare Monroeville Recruiting
Monroeville, Pennsylvania, United States, 15146
Contact: Nicole Lettiere, BA    412-641-8283    lettieren@upmc.edu   
Contact: Bonnie Deyo, BS    412-641-8278    deyob@upmc.edu   
Principal Investigator: Wendie Berg, MD, PhD         
Magee Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Nicole Lettiere, BA    412-641-8283    lettieren@upmc.edu   
Contact: Bonnie Deyo, BS    412-641-8278    deyob@upmc.edu   
Principal Investigator: Wendie Berg, MD, PhD         
Sponsors and Collaborators
Wendie Berg
Breast Cancer Research Foundation
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 of Radiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04085510    
Other Study ID Numbers: STUDY19060359
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
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 participant identification (name, patient number, birth date) will be removed prior to sharing.
Supporting Materials: Study Protocol
Time Frame: At study conclusion
Access Criteria: Participant imaging may be shared with secondary investigators, including commercial companies either by electronic transfers or via disc downloads. All participant identification will be removed prior to the images release.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
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 screening
digital breast tomosynthesis
contrast-enhanced mammogram
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases