Tomosynthesis vs. Contrast-Enhanced Mammography in Women With Personal History of Breast Cancer in Western Pennsylvania (TOCEM)
Primary Purpose
Breast Cancer Female, Breast Cancer, Breast Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contrast-enhanced mammogram
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer Female focused on measuring breast cancer screening, digital breast tomosynthesis, contrast-enhanced mammogram
Eligibility 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) < 45 mL/min
- Pregnancy or lactation
- Women actively being treated for cancer of any type with chemotherapy
- Lump or other breast symptoms
- Abnormality on prior breast imaging that is being followed.
Sites / Locations
- Magee Womancare Passavant CranberryRecruiting
- Magee Womancare MonroevilleRecruiting
- Magee Womens HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contrast-enhanced mammogram
Arm Description
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
Outcomes
Primary Outcome Measures
Cancer Detection
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). Outcomes will be assessed for both prevalence and incidence screens.
Secondary Outcome Measures
Reader Validation
Reader validation will be performed at study conclusion: number of cancers detected with contrast-enhanced mammography or tomosynthesis.
Full Information
NCT ID
NCT04085510
First Posted
September 6, 2019
Last Updated
August 27, 2023
Sponsor
Wendie Berg
Collaborators
Breast Cancer Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04085510
Brief Title
Tomosynthesis vs. Contrast-Enhanced Mammography in Women With Personal History of Breast Cancer in Western Pennsylvania
Acronym
TOCEM
Official Title
Improving Surveillance of Women With Personal History of Breast Cancer Using Contrast-Enhanced Mammography (CEM)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wendie Berg
Collaborators
Breast Cancer Research Foundation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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. Participants will be invited to three rounds of annual screening with CEM. CEM must be performed at the time of or within 6 weeks of routine annual mammogram with tomosynthesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Breast Cancer, Breast Neoplasms, Neoplasms
Keywords
breast cancer screening, digital breast tomosynthesis, contrast-enhanced mammogram
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1650 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contrast-enhanced mammogram
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Contrast-enhanced mammogram
Intervention Description
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 Measure Information:
Title
Cancer Detection
Description
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). Outcomes will be assessed for both prevalence and incidence screens.
Time Frame
48 months
Secondary Outcome Measure Information:
Title
Reader Validation
Description
Reader validation will be performed at study conclusion: number of cancers detected with contrast-enhanced mammography or tomosynthesis.
Time Frame
48 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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) < 45 mL/min
Pregnancy or lactation
Women actively being treated for cancer of any type with chemotherapy
Lump or other breast symptoms
Abnormality on prior breast imaging that is being followed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendie Berg, MD, PhD
Phone
412-641-8283
Email
bergwa@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Allysa Quick, BS
Phone
412-641-8278
Email
quicka@upmc.edu
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
Magee Womancare Passavant Cranberry
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
McKenna Rigling, BS
Phone
412-641-8283
Email
riglingmm@upmc.edu
First Name & Middle Initial & Last Name & Degree
Aerial Kendrick, MS
Phone
412-641-6048
Email
kendrickak@upmc.edu
First Name & Middle Initial & Last Name & Degree
Wendie Berg, MD, PhD
Facility Name
Magee Womancare Monroeville
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aerial Kendrick, MS
Phone
412-641-8278
Email
kendrickak@upmc.edu
First Name & Middle Initial & Last Name & Degree
McKenna Rigling, BS
Phone
412-641-8283
Email
riglingmm@upmc.edu
First Name & Middle Initial & Last Name & Degree
Wendie Berg, MD, PhD
Facility Name
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
McKenna Rigling, BS
Phone
412-641-8283
Email
riglingmm@upmc.edu
First Name & Middle Initial & Last Name & Degree
Aerial Kendrick, MS
Phone
412-641-8278
Email
kendrickak@upmc.edu
First Name & Middle Initial & Last Name & Degree
Wendie Berg, MD, PhD
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 participant identification (name, patient number, birth date) will be removed prior to sharing.
IPD Sharing Time Frame
At study conclusion
IPD Sharing 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.
Learn more about this trial
Tomosynthesis vs. Contrast-Enhanced Mammography in Women With Personal History of Breast Cancer in Western Pennsylvania
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